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RECRUITING
NCT07586943
PHASE1/PHASE2

SKB118 Injection in Advanced Solid Tumors

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, Phase I/II clinical study. The study is divided into two parts, the SKB118 monotherapy study and the SKB118 in combination with SKB264 study.

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB118 Injection in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

530

Start Date

2026-06-01

Completion Date

2030-12

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

SKB118 Injection

SKB118 Injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

DRUG

SKB118+SKB264

Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China