Actively Recruiting
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2024-12-20
186
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
S
Shanghai Junshi Bioscience Co., Ltd.
Lead Sponsor
S
Sponsor GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 75 years
- Histologically or cytologically confirmed advanced solid tumors including esophageal squamous cell carcinoma, gastric/gastroesophageal junction adenocarcinoma (HER2-negative), colorectal adenocarcinoma, or pancreatic ductal adenocarcinoma
- Esophageal cancer patients must have locally advanced unresectable disease or distant metastasis and progressed after first-line PD-(L)1 antibody and platinum-based chemotherapy
- Gastric cancer patients must be HER2-negative with locally advanced unresectable or distant metastases and progressed after first-line PD-(L)1 antibody and platinum-based chemotherapy
- First-line gastric cancer patients with no prior systemic antitumor therapy
- Colorectal cancer patients progressed after first-line 5-FU-based combination therapy
- Pancreatic cancer patients with locally advanced unresectable or metastatic disease with no prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion according to RECIST 1.1
- Adequate organ function
You will not qualify if you...
- Leptomeningeal metastases or active brain metastases
- Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management
- History of interstitial lung disease or noninfectious pneumonia treated with corticosteroids, or active pneumonia on screening imaging
- History of immunodeficiency
- History of serious cardiovascular or cerebrovascular diseases
- History of abdominal or tracheo-esophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
J
Jiangnian Liu, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here