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Spots Global Cancer Trial Database for IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients

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Trial Identification

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

Official Title: 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

Study ID: NCT05830539

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Anyang Tumor Hospital, Anyang, Henan, China

Henan Cancer Hospital, Zhengzhou, Henan, China

Henan Provincial People's Hospital, Zhengzhou, Henan, China

Hubei Cancer Hospital, Wuhan, Hubei, China

Hunan Cancer Hospital, Changsha, Hunan, China

The Third Hospital of Nanchang, Nanchang, Jiangxi, China

Obstetrics & Gynecology Hospital of Fudan University, Shanghai, Shanghai, China

Contact Details

Name: Lingying WU

Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Role: PRINCIPAL_INVESTIGATOR

Name: Xichun Hu

Affiliation: Fudan University

Role: PRINCIPAL_INVESTIGATOR

Name: Dongmei Ji

Affiliation: Fudan University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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