IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients
- Conditions
- Locally Advanced or Metastatic Solid Tumors
- Interventions
- Drug: IN10018+PLDDrug: IN10018+PLD+Toripalimab
- Registration Number
- NCT05830539
- Lead Sponsor
- InxMed (Shanghai) Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Head and Neck Squamous Cell Cancer(R/M-HNSCC) IN10018+PLD 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. Triple Negative Breast Cancer(TNBC) IN10018+PLD 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. Triple Negative Breast Cancer(TNBC) IN10018+PLD+Toripalimab 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. Head and Neck Squamous Cell Cancer(R/M-HNSCC) IN10018+PLD+Toripalimab 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. Platinum-resistant Ovarian Cancer IN10018+PLD+Toripalimab Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer. Small Cell Lung Cancer(SCLC) IN10018+PLD+Toripalimab Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC. Other solid tumor IN10018+PLD 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. Other solid tumor IN10018+PLD+Toripalimab 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. Platinum-sensitive Ovarian Cancer(PSOC) IN10018+PLD+Toripalimab Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.
- Primary Outcome Measures
Name Time Method Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody. Up to 6 Months Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with PLD and Toripalimab.
Objective response rate (ORR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group. Up to 24 Months Defined as the proportion of subjects with complete response (CR) or partial response (PR).
- Secondary Outcome Measures
Name Time Method Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG. Up to 24 Months Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.
Duration of objective response (DOR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group. Up to 24 Months 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.
Disease Control Rate (DCR) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group. Up to 24 Months Defined as the proportion of patients with CR, PR, or stable disease (SD).
Progression-free survival (PFS) per RECIST v1.1 in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group. Up to 24 Months 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.
Overall survival (OS) in IN10018 combined with PLD group or in IN10018 combined with PLD and anti-PD-1 monoclonal antibody group. Up to 36 Months Defined as the time from the start of study treatment to the date of death due to any cause.
Trial Locations
- Locations (7)
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Anyang Tumor Hospital
🇨🇳Anyang, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China