NCT06139211

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
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.
DRUG	Albumin-Bound Paclitaxel	Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-11-01
• Completion: 2026-01-28
• First posted: 2023-11-18
• Last updated: 2024-12-20

Locations

1 site across 1 country: China