CI

At a glance

ClinicalIndex Comparison Record
Phase 1Withdrawn· 0 enrolled
Drug / intervention
JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006drug
Likely dose
JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006 18mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05650203
NCT05650203Phase 1Withdrawn
Withdrawn
CompareCT.gov

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Combination With Toripalimab and JS006 in Patients With Advanced Malignancies

Shanghai Junshi Bioscience Co., Ltd.·interventional·Posted Dec 14, 2022·Updated Apr 5, 2023

In Brief

A Phase 1 clinical trial evaluating JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006 for Primary Condition: Advanced Tumors. Withdrawn before enrollment.

Signals

Trial was withdrawn before enrollment

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Condition: Advanced Tumors
Countries--
Collaborators--

Timeline

Phase 1WithdrawnFinished
20232024202520262027
First PostedDec 14, 2022
Enrollment StartMar 31, 2023
Primary CompletionOct 25, 2025
Study CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 2.6 yearsPosted 3.5 years ago

Interventions

JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006drug

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).