Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.

Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation.

D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation

D-1553

IN10018 orally once daily at approximately the same time each day

IN10018

Debo Nie

Zhengbo Song, MD

Zhengbo Song

This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation

Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Number of subjects participants with adverse events

Defined as the proportion of patients with complete response (CR) or partial response (PR).

InxMed (Shanghai) Co., Ltd.

InventisBio Co., Ltd

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

The safety and tolerability of IN10018 monotherapy will be assessed. Other dose levels may be explored if necessary.

The safety and tolerability of IN10018 in combination with Cobimetinib will be assessed. Other dose levels may be explored if necessary.

A modified 3+3 design will be used.

The safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab will be assessed.

100 mg or 50mg, orally once daily continuously;

60mg , orally once daily from day 1 to day 21 in a 28-day cycle

Cobimetinib

biweekly 840 mg dose will be used in this study starting from Cycle 2.

Eddie Xing, Dr.

Lynn Feun, Dr.

Ryan Sullivan, MD

Rizwan Haq, PhD.

Rachard Carvajal, Dr.

Sapna Patel

Anthony Joshua, MD

Arvin Caraos

Mark Shackleton

Anne Everts

Michal Millward, MD

Kyle Summers

This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and antitumor activities of IN10018 as monotherapy and in combination with cobimetinib in subjects with metastatic uveal melanoma and NRAS-mutant metastatic melanoma.

Subjects with metastatic uveal melanoma (UM) or with NRAS-mutant metastatic melanoma will be enrolled.

IN10018 will be assessed firstly as monotherapy（Part 1）, then in combination with cobimetinib (Part 2) and in combination with cobimetinib and Atezolizumab (Part 3).

The safety and tolerability of IN10018 monotherapy (Part 1) will be assessed firstly. Other dose levels may be explored if necessary.

and then the safety and tolerability of IN10018 in combination with Cobimetinib (Part 2) will be evaluated.

the safety and tolerability of IN10018 in combination with Cobimetinib and Atezolizumab (Part 3) will be evaluated .

IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

A Phase Ib, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of IN10018 as Monotherapy and Combination Therapy in Subjects With Metastatic Melanoma

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Area under the plasma concentration versus time curve (AUC)

Proportion of participants with (complete response, partial response, stable disease, progressive disease) in all 3 parts

Proportion of subjects who have disease control (CR, PR or stable disease (SD)) in all 3 parts

For subjects who demonstrate CR or PR, DOR is defined as the time from first evidence of CR or PR until PD or death due to any cause, whichever occurs first in all 3 parts

PFS is defined as the time from the first day of study treatment to the first disease progression or death due to any cause, whichever occurs first in all 3 parts

OS is defined as the time from the first day of study treatment to death due to any cause in all 3 parts

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Etoposide

Antibodies

Carboplatin

Tislelizumab

Etoposide phosphate

Immunoglobulins

Enzyme Inhibitors

IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.

Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC

Etoposide 100 mg/m2, D1-D3, Q3W, intravenously

Shu Fang

Lily Li

Yuping Sun

Peng Chen

Shundong Cang

Jun Zhao

This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).

This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.

IN10018 Combination Therapy in Treatment-naïve ES-SCLC

A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer

Evaluate proportion of patients suffered with AEs defined as dose-limited toxicities (DLTs) per protocol; and RP2D will be determined per the incidence of AEs defined as DLTs.

Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.

Defined as the proportion of subjects with complete response (CR) or partial response (PR).

Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.

Defined as the proportion of patients with CR, PR, or stable disease (SD).

Defined as the time from randomization to the date of death due to any cause.

The number of participants who experienced AEs is presented.

Area under the concentration-time curve (AUC)

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Disease Attributes

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

Neoplasms, Glandular and Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Placebo of IN10018

40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)

Pegylated Liposomal Doxorubicin

Shangyu CHEN

Lingying WU

This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).

This is a multicenter, randomized, double-blind, Phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).

Approximately 168 subjects will be enrolled into the study. Eligible subjects will be randomized in a 2: 1 ratio to receive IN10018 in combination with PLD treatment (Experimental Arm, N = approx. 112) or placebo of IN10018 in combination with PLD (Control Arm, N = approx. 56). Subjects will be stratified by prior bevacizumab use (yes or no) and platinum free interval (PFI, \< 3 months or 3-6 months).

Subjects will be randomized to one of following treatment arms. The investigator should follow the clinical study protocol, the approved label of these drugs and/or institutional standard of care.

* Experimental Arm: IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).
* Control Arm: Placebo of IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV).

Treatment allocation/randomization will be stratified according to the following factors:

1. Prior bevacizumab use (yes or no).
2. Platinum free interval (PFI, \< 3 months or 3-6 months), 3 months is defined as 90 days.

This is a randomized, double-blind clinical study, therefore, investigator, site staff, subject, and sponsor involved in study will not know the treatment administered. In addition, the central imaging reviewer conducting the BICR evaluation will also be blinded to study treatment allocation.

IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer

PK parameters (i.e., AUC0-τ, Cmax and Ctrough) of IN10018 and PLD, and expose-response relationship of IN10018 by population PK models.

Defined as the proportion of subjects with complete response (CR) or partial response (PR)

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Stomach Cancer

Docetaxel

Tubulin Modulators

Antimitotic Agents

Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.

Participants will be instructed to take IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours. Docetaxel 75mg/m2 every 21 days a cycle.

IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.

Jin Li, Doctor

This is a phase I, multi-center clinical trial to evaluate the safety, tolerability, antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Eligibility patients will be enrolled into the study and assigned to treatment groups: 1) IN10018 monotherapy group, and 2) IN10018+Docetaxel combination group. This study contains 2 parts of dose escalation and dose expansion for each treatment group. The monotherapy group will enroll patients failed to respond to standard therapy or standard or curative therapy does not exist or is not tolerable, and explore IN10018 monotherapy RP2D with the starting dose of IN10018 100mg QD per 3+3 design. The combination group will enroll patients who have disease progression within 3 months after at least first-line therapy, and explore IN10018+docetaxel RP2D with the starting dose of IN10018 100mg QD + docetaxel 75mg/m2 per 3+3 design. The dose expansion part will start after attaining the RP2D of IN10018 monotherapy and IN10018+docetaxel combination therapy.

IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma

A Phase I, Open-label Clinical Trial to Evaluate Safety, Tolerability, Antitumor Activities and Pharmacokinetics of IN10018 as Mono or Combination Therapy in Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Number of patients with adverse event in combination group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in combination group

Number of patients with dose-limited toxicities (DLTs) in combination group

Determine the recommended phase II dose (RP2D) of IN10018 in combination with Docetaxel

Number of patients with adverse event in monotherapy group; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG in monotherapy group

Number of patients with dose-limited toxicities (DLTs) in monotherapy group

Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first

Defined as the proportion of patients with CR, PR, or stable disease (SD)

Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.

Defined as the time from the start of any study treatment to the date of death due to any cause.

Area under the concentration-time curve (AUC).

Antibodies, Monoclonal

Paclitaxel

Albumin-Bound Paclitaxel

Taxane

IN10018 + nab-paclitaxel + Tislelizumab in previously-treated NSCLC

Nab-paclitaxel + Tislelizumab in previously-treated NSCLC

Nab-paclitaxel

Bohong Zhang

Jifeng Feng

This is a phase Ib/II, randomized, open-label, multicenter clinical trial to evaluate the antitumor activities, safety, tolerability and pharmacokinetics (PK) of IN10018 in combination with taxane and anti-PD-1/L1 monoclonal antibody in patients with locally advanced or metastatic solid tumors who have failed in or been intolerant to at least one line of standard therapy. This study will be firstly carried out in previously-treated non-small cell lung cancer (NSCLC) population,

This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the safety and recommended phase II dose (RP2D) of IN10018 in combination with taxane (nab-paclitaxel is proposed) and anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed) in previously-treated solid tumors. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy and safety of IN10018+nab-paclitaxel+Tislelizumab as compared to nab-paclitaxel+Tislelizumab in previously-treated solid tumors. This study will be firstly carried out in previously-treated NSCLC population, and after getting enough efficacy and safety data of IN10018+nab-paclitaxel+Tislelizumab in NSCLC population and also taken into consideration of disease background of other specific solid tumors, sponsor will decide if to expand the treatment regimen into other solid tumors.

IN10018 Combination Therapy in Previously-treated Solid Tumors

A Multicenter, Open-Label, Randomized, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Taxane and Anti-PD-1/L1 Monoclonal Antibody in Previously-treated Solid Tumors

Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with nab-paclitaxel and Tislelizumab.

Carcinoma, Non-Small-Cell Lung

Aflutinib

Protein Kinase Inhibitors

Furmonertinib

Caicun Zhou

This is a multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC.

This study includes 2 parts: Phase Ib-Dose Confirmation and Phase II-Dose Expansion. And 3 cohorts are set up in this study as cohort 1 to enroll subjects currently accepting third-generation EGFR-TKI (Furmonertinib is proposed) as first-line treatment, cohort 2 to enroll subjects who previously accepted third-generation EGFR-TKI treatment and 1-2 lines chemotherapy, and cohort 3 to enroll treatment-naive advanced EGFR mutation-positive NSCLC subjects.

The phase Ib-dose confirmation part will be conducted in cohort 2 and aim to determine the recommended phase II dose (RP2D) of IN10018 in combination with Furmonertinib. Phase II-Dose Expansion part will be conducted in cohort 1-3 and further explore the antitumor efficacy, safety and PK of IN10018 in combination with Furmonertinib in subjects with previously-treated or naïve advanced EGFR mutation-positive NSCLC.

IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

A Multicenter, Open-label, Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Anti-tumor Efficacy of IN10018 Combined With Third-generation EGFR-TKI in Patients With Advanced EGFR Mutation-positive NSCLC

Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced NSCLC.

Defined as the percentage of subjects with the best shrinkage rate of target lesions ≥ 70% and simultaneously with a best response of partial response (PR) or complete response (CR).

Defined as the time from the first dose of study treatment/randomization to first documentation of disease progression or to death due to any cause, whichever comes first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors	NCT05379946	Solid Tumor	D-1553 IN10018	18 Years -	InventisBio Co., Ltd
IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma	NCT04109456	Metastatic Mela...	IN10018 Cobimetinib Atezolizumab	18 Years -	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Treatment-naïve ES-SCLC	NCT06030258	Small Cell Lung...	IN10018 Tislelizumab Carboplatin Etoposide	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer	NCT06014528	Ovarian Cancer ...	IN10018 Placebo of IN10... Pegylated Lipos...	18 Years -	InxMed (Shanghai) Co., Ltd.
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer	NCT06014528	Ovarian Cancer ...	IN10018 Placebo of IN10... Pegylated Lipos...	18 Years -	InxMed (Shanghai) Co., Ltd.
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma	NCT05327231	Gastric Cancer	IN10018 Docetaxel	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Previously-treated Solid Tumors	NCT05982522	Solid Tumor	IN10018 Nab-paclitaxel Tislelizumab	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Previously-treated Solid Tumors	NCT05982522	Solid Tumor	IN10018 Nab-paclitaxel Tislelizumab	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors	NCT05379946	Solid Tumor	D-1553 IN10018	18 Years -	InventisBio Co., Ltd
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors	NCT05379946	Solid Tumor	D-1553 IN10018	18 Years -	InventisBio Co., Ltd
IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC	NCT05994131	NSCLC	IN10018 Furmonertinib	18 Years -	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Treatment-naïve ES-SCLC	NCT06030258	Small Cell Lung...	IN10018 Tislelizumab Carboplatin Etoposide	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.

Spots Global Cancer Trial Database for in10018

Every month we try and update this database with for in10018 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for in10018

Every month we try and update this database with for in10018 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for in10018 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.