Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Antimetabolites

Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study

XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study

telotristat ethyl

Renuka Iyer, M.D.

Richard Kim, M.D.

A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin \[cis\] plus gemcitabine \[gem\])

A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.

A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer

A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.

Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.

Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.

Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.

Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".

Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.

(CR) + partial response (PR) at Months 6

Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.

Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.

Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.

Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.

Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.

Disease control rate (DCR), Local Reviewer, 6 Months

Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)

Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)

Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)

Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)

Mean change in weight at Month 6 from baseline measurement

Mean change in weight at Month 12 from baseline measurement

Mean change in weight from baseline to End of Study

Mean change from Baseline to Month 6 serum albumin levels

Mean change from Baseline to Month 12 serum albumin levels

Mean change from Baseline to End of Study serum albumin levels

TerSera Therapeutics LLC

Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study

telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study

Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

5-HIAA: Normal (\</=) was considered \</= 10.8 micrograms/Liter High (\>ULN) was considered \>10.8 micrograms/Liter

Baseline Plasma 5-Hydroxyindoleacetic Acid (5-HIAA) Levels </= to ULN

Serum CA19-9

Serum CEA

Serum Albumin

This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.

Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.

Janine North, Executive Director-Clinical Development

Safety Population

Per Protocol Population

By Treatment Cycle Population

Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment

Project Overall Survival Rate at Month 6

Overall Survival (OS)

Project Overall Survival Rate at Month 12

Median Progression Free Survival

Disease Control Rate (DCR), Central Radiologist's Assessment

Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment

Overall (Objective) Response Rate, Central Radiologist's Assessment

Summary of Duration of Progression Free Survival, Local Radiologist's Assessment

Progression Free Survival, Local Radiologist's Assessment

Overall (Objective) Response Rate, Local Read

Overall (Objective) Response Rate, Local Reader's Assessment

Overall (Objective) Response Rate (ORR), Local Reader's Assessment

Disease Control Rate (DCR), Local Reviewer

Disease Control Rate End of Study, Local Reviewer

Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)

Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)

Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)

Weight Change From Baseline

Change From Baseline in Serum Albumin

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Colorectal Neoplasms

Endometrial Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

Vitamins

Paclitaxel

Leucovorin

Fluorouracil

Albumin-Bound Paclitaxel

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.

INCB001158

Oxaliplatin administered intravenously at the protocol-defined dose and schedule.

Leucovorin at the protocol-defined dose and regimen.

5-Fluorouracil at the protocol-defined dose and regimen.

5-Fluorouracil

Gemcitabine at the protocol-defined dose and regimen.

Cisplatin at the protocol-defined dose and regimen.

Paclitaxel at the protocol-defined dose and regimen.

Lance Leopold, MD

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.

The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.

ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.

DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.

Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.

Incyte Corporation

Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-defined in the Statistical Analysis Plan, data analysis was conducted based on treatment group and dose level, regardless of study phase, because the safety profile was expected to be generally uniform across tumor types.

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or solid metastatic tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with BTC or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. In Phase 1, participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 25 mg/m\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and 8 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel

In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and GC, EC, or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) also received intravenous paclitaxel 80 mg/m\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.

Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel

Total

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \[m\^2\], leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1: INCB001158 50 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.

Phase 1: INCB001158 75 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2, and 5-fluorouracil 400 mg/m\^2 \[bolus\] and 2400 mg/m\^2 \[continuous infusion\]) on Day 1 and Day 15 of each 28-day cyce after administration of INCB001158.

Phase 1: INCB001158 100 mg + mFOLFOX6

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle.

Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin

In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\^2 and intravenous cisplatin 30 mg/m\^2 on Day 1 and Day 8 of each 28-day cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer	NCT03790111	Biliary Tract C...	telotristat eth...	18 Years -	TerSera Therapeutics LLC
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors	NCT03314935	Biliary Tract C... Colorectal Canc... Endometrial Can... Gastroesophagea... Ovarian Cancer Solid Tumors	INCB001158 Oxaliplatin Leucovorin 5-Fluorouracil Gemcitabine Cisplatin Paclitaxel	18 Years -	Incyte Corporation
AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors	NCT05094336	Advanced MTAP-n...	AMG 193 Docetaxel Comparator AMG ...	18 Years - 100 Years	Amgen
AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors	NCT05094336	Advanced MTAP-n...	AMG 193 Docetaxel Comparator AMG ...	18 Years - 100 Years	Amgen
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)	NCT05041972	HER2 Mutation-R... HER2 Amplified ...	ARX788	18 Years -	Ambrx, Inc.
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors	NCT03314935	Biliary Tract C... Colorectal Canc... Endometrial Can... Gastroesophagea... Ovarian Cancer Solid Tumors	INCB001158 Oxaliplatin Leucovorin 5-Fluorouracil Gemcitabine Cisplatin Paclitaxel	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for biliary tract cancer (btc)