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

Sponsor
Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.
Study ID
NCT05824455
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 23, 2023
Status verified
Sep 2024
Primary completion
Sep 28, 2023
Completion
Sep 28, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: JS109 combination with irinotecan

Primary Outcome Measure

Incidence of DLT [ Time Frame: Up to approximately 16 months from first patient in. ]

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