A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
Hutchmed
Study ID
NCT07228247
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumors, Adult

Eligibility Criteria

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

Interventions

  • HMPL-A251 — DRUG
    Six dose cohorts are planned for the Dose Escalation phase; at least three participants with solid tumors will be enrolled in each dose cohort. Bayesian optimal interval design with backfill (BF-BOIN, Zhao, 2023) will be used to guide dose escalation and determine the MTD and/or RDE of HMPL-A251. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.
  • HMPL-A251 — DRUG
    Participants will be randomized in a 1:1 ratio to receive treatment in two RDEs levels (approximately 15 participants per dose level) for each cohort. All study participants will receive HMPL-A251 as IV infusion until PD, intolerable toxicity, or other protocol-specified criteria for ending study treatment, whichever occurs first.

Study Details

This is a first-in-human (FIH), phase Ⅰ/Ⅱa, open-label, multicenter clinical study of HMPL-A251 monotherapy in adult participants with unresectable, advanced or metastatic HER2-expressing solid tumors.

Key Dates

Start date
Dec 16, 2025
Status verified
May 2026
Primary completion
Nov 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
147 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A(Phase I)
    Dose Escalation
  • Experimental: Part B(Phase IIa)
    Dose Expansion/Dose Optimization

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 12 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
SCRI HealthONEDenverColorado80218
Gerald Falchook
[email protected]
940-365-6217
BRCR GlobalPlantationFlorida33322
Harshad Amin
[email protected]
561-447-0614
Florida Clinical Trials Group LLC (Plantation)PlantationFlorida33322
Harshad Amin
Florida Clinical Trials Group LLC (Tamarac)TamaracFlorida33321
Chintan Ghandi
START New JerseyEast BrunswickNew Jersey08816
Bruno Fang
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Vicky Makker
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195
WenWee Ma
[email protected]
216-559-9815
Mays Cancer CenterSan AntonioTexas78229
Daruka Mahadevan
Northwest Medical Specialties, PLLCTacomaWashington98405
Jorge Chaves

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By research site
SCRI HealthONE· Denver, COBRCR Global· Plantation, FLFlorida Clinical Trials Group LLC (Plantation)· Plantation, FLFlorida Clinical Trials Group LLC (Tamarac)· Tamarac, FLSTART New Jersey· East Brunswick, NJMemorial Sloan Kettering Cancer Center· New York, NY

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