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A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

NCT05824455 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-09-05

No results posted yet for this study

Summary

The Phase Ib study was designed to evaluate the safety of JS109 in combination with irinotecan in the treatment of advanced solid tumors and to determine the Phase II recommended dose (RP2D). The Phase II study was designed to evaluate the efficacy and safety of the combination regimen in patients with extensive small-cell lung cancer (SCLC) that failed first-line platinum-containing regimen.

Conditions

Interventions

COMBINATION_PRODUCT

JS109 combine with irinotecan

JS109 PO,QD, q3w combine with irinotecan(65mg/m2,IV,D1,8,Q3w)

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2023-09-28
Completion
2023-09-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05824455 on ClinicalTrials.gov