A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors
NCT ID: NCT07228247
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
147 participants
INTERVENTIONAL
2025-12-16
2028-12-31
Brief Summary
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Detailed Description
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* To characterize the safety and preliminary efficacy of HMPL-A251 at RDEs to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected HER2-expressing solid tumors
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A(Phase I)
Dose Escalation
HMPL-A251
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.
Part B(Phase IIa)
Dose Expansion/Dose Optimization
HMPL-A251
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.
Interventions
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HMPL-A251
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
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.
Eligibility Criteria
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Inclusion Criteria
2. Have at least one measurable lesion per RECIST v1.1;
3. Life expectancy ≥ 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
5. Weight ≥ 35 kg;
Exclusion Criteria
2. Use of strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug;
3. Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy);
4. Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant;
5. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
6. Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s);
18 Years
ALL
No
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Locations
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SCRI HealthONE
Denver, Colorado, United States
BRCR Global
Plantation, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Peking University First Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
Fujian Cancer Hospital
Fujian, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Facility Contacts
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Gerald Falchook
Role: primary
Harshad Amin
Role: primary
Vicky Makker
Role: primary
WenWee Ma
Role: primary
Brent Rexer
Role: primary
Shikai Wu
Role: primary
Quchang Oyang
Role: primary
Fan Wu
Role: primary
Shusen Wang
Role: primary
Yingying Du
Role: primary
Min Yan
Role: primary
Other Identifiers
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2025-251-GLOB1
Identifier Type: -
Identifier Source: org_study_id