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

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05277168
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1904 — DRUG
    Single Arm ：It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors

Study Details

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.

Key Dates

Start date
May 30, 2022
Status verified
May 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: Single Arm
    Single Arm : SHR-A1904

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: The first cycle of administration, up to 21 days. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Comprehensive Hematology OncologySt. PetersburgFlorida33709-
LSU Health Sciences CenterNew OrleansLouisiana70112-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Rhode Island HospitalProvidenceRhode Island02905-
Prisma HealthGreenvilleSouth Carolina29605-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Miami Beach, FL

By research site
Mount Sinai Comprehensive Cancer Center· Miami Beach, FLComprehensive Hematology Oncology· St. Petersburg, FLLSU Health Sciences Center· New Orleans, LAUniversity Hospitals Cleveland Medical Center· Cleveland, OHRhode Island Hospital· Providence, RIPrisma Health· Greenville, SC

Related Studies