A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

Sponsor
Innolake Biopharm
Study ID
NCT05955105
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ILB-2109 — DRUG
    ILB-2109 tablets will be administered by mouth every day in 21-day cycles
  • Toripalimab — DRUG
    Toripalimab injection will be administered via IV every 21 days.

Study Details

This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.

Key Dates

First listed
Jul 21, 2023
Start date
Jul 25, 2023
Status verified
May 2024
Primary completion
Jan 25, 2026
Completion
Jul 24, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Subjects will receive ILB-2109 tablets and Toripalimab injection

Primary Outcome Measure

The Incidence of DLTs [ Time Frame: Cycle 1 (21 days) ]

Central Contacts

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