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

November 17, 2023 updated by: Shanghai Junshi Bioscience Co., Ltd.

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 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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai East Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: esophogeal squamous carcinoma
In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Experimental: Cohort 2: gastric cancer
In Cohort 2, patients will be treated with JS015 in combination with paclitaxel
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Experimental: Cohort 3: gastric cancer
In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Experimental: Cohort 4: colorectal cancer
In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Bevacizumab will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Experimental: Cohort 5: pancreatic cancer
In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of dose-limiting toxicity (DLT)
Time Frame: 2 Years
incidence and severity of DLT
2 Years
incidence of adverse event(AE)
Time Frame: 2 Years
adverse events (AE)
2 Years
Recommended dose for phase II trial RP2D
Time Frame: 2 Years
Recommended dose for phase II trial
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunogenicity
Time Frame: 2 years
Incidence of Anti-Drug Antibody (ADA)
2 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Time Frame: 2 years
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
2 years
Peak concentration (Cmax)
Time Frame: 2 years
The highest plasma drug concentration that can be achieved after medication
2 years
time to peak concentration(Tmax)
Time Frame: 2 years
The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration
2 years
elimination half life(t1/2)
Time Frame: 2 years
The time it takes for the concentration of the drug in the plasma to be reduced by 50%
2 years
Progression free survival (PFS)
Time Frame: 2 years
The time from first dose to Disease progression or death
2 years
overall survival (OS)
Time Frame: 2 years
The time from first dose to death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumor

Clinical Trials on JS015

Subscribe