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NOT YET RECRUITING
NCT07750132
PHASE1

Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors

Sponsor: Beijing StarMab Biomed Technology Ltd

View on ClinicalTrials.gov

Summary

This is a first-in-human, multicenter, open-label Phase Ia/Ib study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of SM2275 in patients with advanced or metastatic solid tumors who have progressed after standard therapy or for whom no standard treatment is available. Phase Ia includes dose escalation to evaluate safety, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Phase Ib will further evaluate safety, PK, PD, and preliminary antitumor activity in expansion cohorts.

Official title: A First-in-Human, Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of SM2275 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-09-20

Completion Date

2029-02-02

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

SM2275

Concentrated solution for injection, 100 mg/4 mL/vial. Administered intravenously according to preset dose levels and cycle intervals defined in protocol v1.0.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China