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
Overview
- Phase
- Phase 1
- Intervention
- IN10018+PLD
- Conditions
- Locally Advanced or Metastatic Solid Tumors
- Sponsor
- InxMed (Shanghai) Co., Ltd.
- Enrollment
- 68
- Locations
- 7
- Primary Endpoint
- Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Triple Negative Breast Cancer(TNBC)
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.
Intervention: IN10018+PLD
Triple Negative Breast Cancer(TNBC)
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.
Intervention: IN10018+PLD+Toripalimab
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
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.
Intervention: IN10018+PLD
Head and Neck Squamous Cell Cancer(R/M-HNSCC)
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.
Intervention: IN10018+PLD+Toripalimab
Platinum-resistant Ovarian Cancer
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with platinum-resistant ovarian cancer.
Intervention: IN10018+PLD+Toripalimab
Platinum-sensitive Ovarian Cancer(PSOC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with Platinum-sensitive recurrent ovarian cancer.
Intervention: IN10018+PLD+Toripalimab
Small Cell Lung Cancer(SCLC)
Group 2: IN10018 in combination with PLD and anti-PD-1 monoclonal antibody in Subjects with previously-treated locally advanced or metastatic SCLC.
Intervention: IN10018+PLD+Toripalimab
Other solid tumor
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.
Intervention: IN10018+PLD
Other solid tumor
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.
Intervention: IN10018+PLD+Toripalimab
Outcomes
Primary Outcomes
Recommended phase II dose (RP2D) of IN10018 in combination with PLD and anti-PD-1 monoclonal antibody.
Time Frame: 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.
Time Frame: Up to 24 Months
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Secondary Outcomes
- Number of patients with adverse event; Number of patients with laboratory abnormalities, abnormal vital signs and abnormal 12-lead ECG.(Up to 24 Months)
- 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)
- 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)
- 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)
- 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)