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

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT06139211
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JS015 — BIOLOGICAL
    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 — BIOLOGICAL
    Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Paclitaxel — BIOLOGICAL
    Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Irinotecan — DRUG
    Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Capecitabine — DRUG
    Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
  • Bevacizumab — BIOLOGICAL
    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.
  • Fluorouracil — DRUG
    Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Leucovorin — DRUG
    Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
  • Gemcitabine — DRUG
    Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
  • Albumin-Bound Paclitaxel — DRUG
    Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Study Details

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.

Key Dates

Start date
Jan 3, 2024
Status verified
Dec 2024
Primary completion
Nov 1, 2025
Completion
Jan 28, 2026

Study Design

Enrollment
186 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: esophogeal squamous carcinoma
    In Cohort 1, patients will be treated with JS015 in combination with paclitaxel or irinotecan
  • Experimental: Cohort 2: gastric cancer
    In Cohort 2, patients will be treated with JS015 in combination with paclitaxel
  • Experimental: Cohort 3: gastric cancer
    In Cohort 3, patients will be treated with JS015 in combination with toripalimab and XELOX
  • Experimental: Cohort 4: colorectal cancer
    In Cohort 4, patients will be treated with JS015 plus bevacizumab in combination with XELOX or FOLFIRI
  • Experimental: Cohort 5: pancreatic cancer
    In Cohort 5, patients will be treated with JS015 in combination with toripalimab, albumin-bound paclitaxel and gemcitabine

Primary Outcome Measure

incidence of dose-limiting toxicity （DLT） [ Time Frame: 2 Years ]

Central Contacts

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