Overview

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

Status:
Not yet recruiting
Trial end date:
2026-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Collaborator:
Sponsor GmbH
Treatments:
Albumin-Bound Paclitaxel
Bevacizumab
Capecitabine
Fluorouracil
Gemcitabine
Irinotecan
Leucovorin
Oxaliplatin
Paclitaxel
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