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

Shanghai Junshi Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Leucovorin; Drug: Irinotecan; Biological: Paclitaxel; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Albumin-Bound Paclitaxel; Biological: JS015; Drug: Fluorouracil; Biological: Toripalimab; Drug: Gemcitabine; Biological: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06139211

JS015-002-Ib/II-GI

Details and patient eligibility

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who meet the following criteria for each indication cohort:

2. 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;

3. 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;

4. 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;

5. 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;

6. 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 5 patient groups

Cohort 1: esophogeal squamous carcinoma

Experimental group

Description:

In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan

Treatment:

Biological: JS015

Drug: Irinotecan

Biological: Paclitaxel

Cohort 2: gastric cancer

Experimental group

Description:

In Cohort 2, patients will be treated with JS015 in combination with paclitaxel

Treatment:

Biological: JS015

Biological: Paclitaxel

Cohort 3: gastric cancer

Experimental group

Description:

In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX

Treatment:

Biological: Toripalimab

Biological: JS015

Drug: Capecitabine

Drug: Oxaliplatin

Cohort 4: colorectal cancer

Experimental group

Description:

In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI

Treatment:

Biological: Bevacizumab

Drug: Fluorouracil

Biological: JS015

Drug: Capecitabine

Drug: Oxaliplatin

Drug: Irinotecan

Drug: Leucovorin

Cohort 5: pancreatic cancer

Experimental group

Description:

In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine

Treatment:

Drug: Gemcitabine

Biological: Toripalimab

Drug: Albumin-Bound Paclitaxel

Biological: JS015