Status:
RECRUITING
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 1\. 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;
- 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;
- 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;
Exclusion
- 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
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06139211
Start Date
January 3 2024
End Date
January 28 2026
Last Update
December 20 2024
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120