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Recruiting NCT06139211

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

Phase I / Phase II Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JS015, Toripalimab, Paclitaxel, Irinotecan.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological JS015
    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.
  • Biological Toripalimab
    Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Biological Paclitaxel
    Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Drug Irinotecan
    Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Drug Capecitabine
    Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
  • Drug Oxaliplatin
    Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Biological Bevacizumab
    Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy.
  • Drug Fluorouracil
    Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Drug Leucovorin
    Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Drug Gemcitabine
    Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Primary outcome measures

  • incidence of dose-limiting toxicity （DLT） [Time frame: 2 Years]
  • incidence of adverse event（AE） [Time frame: 2 Years]
  • Recommended dose for phase II trial RP2D [Time frame: 2 Years]
Secondary outcome measures (7)
  • Peak concentration (Cmax) [Time frame: 2 years]
  • time to peak concentration（Tmax） [Time frame: 2 years]
  • elimination half life（t1/2） [Time frame: 2 years]
  • immunogenicity [Time frame: 2 years]
  • Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) [Time frame: 2 years]
  • Progression free survival (PFS) [Time frame: 2 years]
  • overall survival (OS) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

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

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

  • Leptomeningeal metastases and /or active brain metastases;
  • Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);
  • History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;
  • History of immunodeficiency;
  • History of serious cardiovascular and/or cerebrovascular diseases;
  • History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT06139211 · JS015-002-Ib/II-GI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗