A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

Eligibility criteria

Qualifiers

Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.

Age > 18.

ECOG performance status of 0-1.

Life expectancy of ≥ 3 months.

Disqualifiers

Plan to receive any other anti-tumor treatments during the treatment period of this study.

Subjects participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.

Underwent major surgical operation within 4 weeks before the first dose of this IP.

Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within < 5 half-lives of the drug before the first dose of the study.

Trial design

Treatments tested in this trial

  • SHR-A1904

Treatment groups

83 Participants
are divided into 1 treatment group