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Group 1: IN10018 in combination with PLD in Subjects with previously-treated locally advanced or metastatic TNBC.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic TNBC.

Group 1: IN10018 in combination with PLD in Subjects with previously-treated R/M-HNSCC.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated R/M-HNSCC.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC.

Group 1: IN10018 in combination with PLD in Subjects with other previously-treated locally advanced or metastatic solid tumors.

Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with other previously-treated locally advanced or metastatic solid tumors.

IN10018 orally once daily; PLD 40mg/m2, Q4W

IN10018+PLD

IN10018 orally once daily; PLD 40mg/m2, Q4W; Toripalimab 3 mg/kg, Q2W

IN10018+PLD+Toripalimab

Lingying WU

Xichun Hu

Dongmei Ji

This is a multicenter, open-label, Phase Ib/II clinical trial to evaluate the safety, tolerability, and antitumor efficacy of IN10018 in combination with pegylated liposomal doxorubicin (PLD) or IN10018 in combination with PLD and anti-PD-1 in subjects with locally advanced or metastatic solid tumors who have failed or not tolerated to at least first-line system therapy.

This study is a phase Ib/II, multicenter, open-label clinical study. This study consists of 2 parts: 1) Efficacy exploration part: including phase-Ib study (dose confirmation part) and phase II study, the purpose of phase Ib-dose confirmation part is to determine the Phase II recommended dose (RP2D) of IN10018 in combination with Pegylated liposomal doxorubicin (PLD) and programmed death-1 (PD-1) monoclonal antibody. The Phase II study will explore the antitumor efficacy and safety of IN10018 in combination with PLD or IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in subjects with locally advanced or metastatic solid tumors who have failed or are intolerant to at least first-line system therapy; 2) Efficacy confirmation part: The antitumor efficacy and safety of combination therapy in the corresponding solid tumors will be further confirmed.

IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

A Phase Ib/II, Open-label, Multicenter Clinical Study to Evaluate the Antitumor Activities, Safety, and Tolerability of IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

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

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

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

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 study treatment to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients	NCT05830539	Locally Advance...	IN10018+PLD IN10018+PLD+Tor...	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients	NCT05830539	Locally Advance...	IN10018+PLD IN10018+PLD+Tor...	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.
IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients	NCT05830539	Locally Advance...	IN10018+PLD IN10018+PLD+Tor...	18 Years - 75 Years	InxMed (Shanghai) Co., Ltd.

Spots Global Cancer Trial Database for in10018+pld

Every month we try and update this database with for in10018+pld 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+pld

Every month we try and update this database with for in10018+pld 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+pld 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.