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RECRUITING
NCT06139211
PHASE1/PHASE2

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

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-01-03

Completion Date

2026-01-28

Last Updated

2024-12-20

Healthy Volunteers

No

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.

DRUG

Albumin-Bound Paclitaxel

Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China