Combination therapy for advanced solid tumors

A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors

This study is testing a new combination of treatments for people with advanced solid tumors to see how safe it is and how well it works.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06139211 on ClinicalTrials.gov

What this trial studies

This phase Ib/II study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of a combination therapy involving JS015, Toripalimab, Paclitaxel, Irinotecan, and Capecitabine in patients with advanced solid tumors. The study aims to determine the recommended dose for the phase II trial based on the collected data. It is an open-label, multicenter trial that includes various cohorts based on specific cancer types and treatment histories.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced esophageal, gastric, or colorectal cancers who have progressed after prior treatments.

Not a fit: Patients with early-stage tumors or those who have not received prior systemic antitumor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors who have limited options.

How similar studies have performed: Other studies have shown promise with combination therapies in advanced solid tumors, suggesting potential for success in this approach.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jiangnian Liu, PM

Conditions: Advanced Solid Tumor