SKB565 for Injection in Advanced Solid Tumors

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07545265
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • SKB565 — DRUG
    IV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).

Study Details

This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.

Key Dates

First listed
Apr 22, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: SKB565 monotherapy
    SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Primary Outcome Measure

Number of subjects achieving Dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days) ]

Central Contacts

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