MedTrace Logo

A Study of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Patients With Advanced Malignancies

NCT05650203 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-05

No results posted yet for this study

Summary

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006 in Patients with Advanced Malignancies, also to explore the RP2D of JS009.

Conditions

  • Primary Condition: Advanced Tumors

Interventions

DRUG

JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006

1. JS009 as Monotherapy in first cycle of dose escalation and as the triple combination therapy will be administered in subsequent cycles：JS009,18mg/60mg/180mg/600mg/1200mg, JS006, fixed dose 600mg, Toripalimab injection fixed dose 240mg,IV infusion, every 3 weeks (q3w). 2. Triple combination therapy in dose expansion：JS009, 1 or 2 specific dose, with fixed dose of JS006 and Toripalimab Injection, IV infusion, every 3 weeks (q3w). 3. Triple combination therapy in indication expansion：JS009, 1 specific dose, with fixed dose of JS006 and Toripalimab Injection, IV infusion, every 3 weeks (q3w).

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Yilong WU, Ph.D · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2025-10-25
Completion
2026-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650203 on ClinicalTrials.gov