A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors

Launched by SHANGHAI JUNSHI BIOSCIENCE CO., LTD. · Nov 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JS015 in combination with other therapies for patients with advanced solid tumors, such as esophageal, gastric, colorectal, and pancreatic cancers. The goal is to understand how safe the treatment is, how well it works, and to figure out the best dose to use in future studies. This trial is currently recruiting participants who are between 18 and 80 years old and have specific types of cancer that have not responded to previous treatments.

To be eligible for this trial, patients must have a confirmed diagnosis of certain advanced cancers and have experienced disease progression after standard treatments. Participants can expect to receive the JS015 combination therapy under close medical supervision and will be monitored for any side effects or improvements in their condition. It's essential for potential participants to discuss with their doctor if they meet the criteria and if this trial might be a suitable option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Patients who meet the following criteria for each indication cohort:
• • 1. 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;
• • 2. 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;
• • 3. 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;
• • 4. 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;
• • 5. 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 Criteria:
• • 1. Leptomeningeal metastases and /or active brain metastases;
• • 2. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
• • 3. History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
• • 4. History of immunodeficiency;
• • 5. History of serious cardiovascular and/or cerebrovascular diseases;
• • 6. History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration