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JS001+IMP4297 in Patients With Advanced Cancer

NCT05262842 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-09-21

No results posted yet for this study

Summary

This is a Phase I/Ib open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of toripalimab in combination with senaparib in patients with advanced solid tumors. The study consists of 2 parts, the Phase I part of the study will be a dose-escalation evaluation to determine the RP2D of senaparib to be administered in combination with the fixed dose of toripalimab, and the Phase Ib portion will further evaluate the RP2D and evaluate the efficacy of combination in specific types of advanced solid tumors.

Conditions

Interventions

DRUG

JS001+IMP4297

Phase I: Dose Escalation The primary endpoints are the safety and tolerability of the combination, including the incidence and nature of DLTs and the determination of the MTD and RP2D. A 3 + 3 dose-escalation (60mg,80mg,100mg)design will be used. Patient in each dose level will be treated with toripalimab 240mg in combination with senaparib. Phase Ib: Dose Expansion This part will commence after the RP2D is determined and will further evaluate the safety and anti-tumor activity of toripalimab and senaparib in patients with specific types of advanced solid tumors. Patients will be enrolled concurrently into 5 exploratory cohorts with approximately 20 patients each cohort.

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Principal Investigators

  • Li Zhang, M.D. · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2024-04-06
Completion
2024-06-06

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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 NCT05262842 on ClinicalTrials.gov