Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Gastrointestinal Neoplasms

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Digestive System Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mixed Mullerian Tumor

Uterine Carcinosarcoma

INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles.

Subsequent dose regimens will be determined during study conduct.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma ) will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Endometrial/Uterine cancer will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with HR+/HER2- breast cancer who have had disease progression on or been intolerant of a CDK4/6 inhibitor will enroll in this group.

INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with other tumor indications with CCNE1 amplification or cyclin E1 over-expression will enroll in this group.

INCB0123667

Incyte Corporation Call Center (US)

Incyte Corporation Call Center (ex-US)

Liz Croft Richards

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy at the RDE(s) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) will determine the recommended dose of INCB123667 for expansion (RDE) and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in 6 tumor-specific cohorts at the RDE(s) defined in Part 1A.

Part 1a will be dose escalation using a statistical hybrid design to identify the RDE(s), and the starting dose of INCB123667 will be 50mg QD. Part 1B is a dose expansion portion during which drug will be administered at the RDE(s) defined in Part 1A to 6 Disease Groups.

Study of INCB123667 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors

Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.

TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.

TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Defines as the maximum (peak) plasma drug concentration

Defined as the time to reach maximum (peak) plasma concentration following drug administration

Ctau is defined as concentration at the end of the dosing interval

Defined as the area under the plasma concentration-time curve

Defined as the apparent total body clearance of the drug from plasma

Defined as apparent volume of distribution during terminal phase

Defined as Elimination half-life (to be used in one-or noncompartmental model)

Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1.

Defined as the time from earliest date of disease response (Completed Rresponse or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression.

Incyte Corporation

Sarcoma

Soft Tissue Sarcoma

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Carbamide Peroxide

Trametinib

Dabrafenib

patients treated with dabrafenib and trametinib

Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program

Non-investigational

Novartis Pharmaceuticals

Emily Bolch

John Strickler

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.

Defined as time from the onset of tumor response until the date of the first documented progressive disease (PD) or death due to any cause.

Defined as the proportion of study participants with a best overall response of CR, PR or stable disease (SD), lasting as per independent central review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST v1.1. or other relevant response criteria.

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Lung Neoplasms

Hypersensitivity

Urinary Bladder Neoplasms

Leiomyosarcoma

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Fallopian Tube Cancer

Herbal and Botanical

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Enzyme Inhibitors

Cola

Eligible participants will be enrolled in either Cohort A or Cohort B.

Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.

Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Kim Reiss-Binder, MD

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

Measure of clinical benefit, defined as the duration from study enrollment to death.

pharmaand GmbH

Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Rucaparib Cohort B

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kim Reiss Binder

Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).

Best Overall Response Rate by Investigator

No data were collected as the independent radiology review was not performed.

Overall Response Rate by Independent Radiology Review

Participants with a deleterious mutation in one of the following genes: BRD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Duration of Response

Disease Control Rate

Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors	NCT05868629	Rare Unresectab...	Non-investigati...	6 Years -	Novartis
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
Study of INCB123667 in Subjects With Advanced Solid Tumors	NCT05238922	Solid Tumors	INCB0123667	18 Years -	Incyte Corporation
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes	NCT04171700	Solid Tumor	Rucaparib	18 Years -	pharmaand GmbH
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors	NCT05868629	Rare Unresectab...	Non-investigati...	6 Years -	Novartis
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors	NCT05868629	Rare Unresectab...	Non-investigati...	6 Years -	Novartis

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