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

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

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.

Sponsors & Collaborators

• Sponsor GmbH

  collaborator OTHER

• Shanghai Junshi Bioscience Co., Ltd.

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-03

Primary Completion

2025-11-01

Completion

2026-01-28

Countries

• China

Study Locations