HMPL-A830 in Solid Tumors

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors

This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:

Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.

Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: HMPL-A830; Drug: HMPL-A830

Detailed Description

Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.

Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
    • Contact: Lin Shen
  • Changsha, China
    • Hunan Cancer Hospital
    • Contact: Yongchang Zhang
  • Chengdu, China
    • West China Hospital of Sichuan University
    • Contact: Li Zheng
  • Guangzhou, China
    • The Sixth Affiliated Hospital,Sun Yat-sen University
    • Contact: Yanhong Deng
  • Jinan, China
    • Shandong Cancer Hospital
    • Contact: shuqin Ni
  • Nanjing, China
    • Jiangsu Province Hospital
    • Contact: Xiaofeng Chen
  • Taiyuan, China
    • Shanxi Provincial Cancer Hospitial
    • Contact: Hongxia Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understood this study and are able to voluntarily sign the informed consent form (ICF);
2. Male or Female, Age ≥ 18 years;
3. Histological confirmed, unresectable, advanced or metastatic solid tumor
4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

Exclusion Criteria:

1. Use 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
2. Major surgery within 28 days prior to the first dose of study drug
3. Active infection requiring systemic treatment
4. History of inflammatory gastrointestinal diseases
5. Known hypersensitivity to any component of HMPL-A830
6. Pregnant (positive pregnancy test) or lactating;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Dose Escalation)	Drug: HMPL-A830; Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels; Drug: HMPL-A830; Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
Experimental: Part B (Dose Optimization)	Drug: HMPL-A830; Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels; Drug: HMPL-A830; Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLTs	Number of Participants With of DLTs	Approximately 12 months
Overview of Treatment-emergent Adverse Events (TEAEs)	The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0	Approximately 12 months
Objective Response Rate (ORR)	Assessed by investigators according to RECIST 1.1	Approximately 24 months
Recommended doses for phase II or III studies (RP2D or RP3D)	The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.	Approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	The time from the first dose of study drug to the date of first radiographic PD per RECIST v1.1 or death due to any cause, whichever occurs first.	Approximately 2 years
Disease control rate (DCR)	The DCR by RECIST 1.1	Approximately 2 years
Pharmacokinetic Analysis(Cmax)	Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)	Approximately 2 years
Pharmacokinetic Analysis (Cmin)	Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)	Approximately 2 years
Pharmacokinetic Analysis(Tmax)	Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)	Approximately 2 years
Pharmacokinetic Analysis((AUClast)	Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)	Approximately 2 years
Pharmacokinetic Analysis((AUCtau)	Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)	Approximately 2 years
Incidence of anti-drug antibodies (ADAs) against HMPL-A830	Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.	Approximately 2 years

Collaborators and Investigators

• Sponsor: Hutchmed

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): June 26, 2028
• Study Completion (Estimated): November 26, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-830-GLOB1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No