The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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