A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Registration Number
- NCT06139211
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 186
-
Patients who meet the following criteria for each indication cohort:
-
Esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
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Gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, HER2-negative, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;
-
1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;
-
Colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-FU-based combination therapy;
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Pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy >=12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;
- Leptomeningeal metastases and /or active brain metastases;
- Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
- History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
- History of immunodeficiency;
- History of serious cardiovascular and/or cerebrovascular diseases;
- History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 5: pancreatic cancer Albumin-Bound Paclitaxel In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine Cohort 3: gastric cancer JS015 In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX Cohort 4: colorectal cancer JS015 In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 5: pancreatic cancer JS015 In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine Cohort 1: esophogeal squamous carcinoma JS015 In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan Cohort 1: esophogeal squamous carcinoma Paclitaxel In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan Cohort 1: esophogeal squamous carcinoma Irinotecan In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan Cohort 2: gastric cancer JS015 In Cohort 2, patients will be treated with JS015 in combination with paclitaxel Cohort 2: gastric cancer Paclitaxel In Cohort 2, patients will be treated with JS015 in combination with paclitaxel Cohort 3: gastric cancer Toripalimab In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX Cohort 3: gastric cancer Capecitabine In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX Cohort 3: gastric cancer Oxaliplatin In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX Cohort 4: colorectal cancer Irinotecan In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 4: colorectal cancer Capecitabine In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 4: colorectal cancer Oxaliplatin In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 4: colorectal cancer Bevacizumab In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 4: colorectal cancer Fluorouracil In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 4: colorectal cancer Leucovorin In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI Cohort 5: pancreatic cancer Toripalimab In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine Cohort 5: pancreatic cancer Gemcitabine In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine
- Primary Outcome Measures
Name Time Method incidence of dose-limiting toxicity （DLT） 2 Years incidence and severity of DLT
incidence of adverse event（AE） 2 Years adverse events (AE)
Recommended dose for phase II trial RP2D 2 Years Recommended dose for phase II trial
- Secondary Outcome Measures
Name Time Method Peak concentration (Cmax) 2 years The highest plasma drug concentration that can be achieved after medication
time to peak concentration（Tmax） 2 years The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration
elimination half life（t1/2） 2 years The time it takes for the concentration of the drug in the plasma to be reduced by 50%
immunogenicity 2 years Incidence of Anti-Drug Antibody (ADA)
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) 2 years Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Progression free survival (PFS) 2 years The time from first dose to Disease progression or death
overall survival (OS) 2 years The time from first dose to death from any cause
Trial Locations
- Locations (1)
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China