HMPL-A830 in Solid Tumors

NCT07718581 · tracked via the Priya Life Science USA tracker

Sponsor

Hutchmed

Phase

Phase 1/2

Started

2026-09-24

Last updated

2026-10-01

Condition(s) studied

Solid Tumor, Adult

Investigational drug(s) / intervention(s)

HMPL-A830HMPL-A830

HMPL-A830: Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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;

Primary outcome measure(s)

DLTs — Approximately 12 months
Number of Participants With of DLTs
Overview of Treatment-emergent Adverse Events (TEAEs) — Approximately 12 months
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Objective Response Rate (ORR) — Approximately 24 months
Assessed by investigators according to RECIST 1.1
Recommended doses for phase II or III studies (RP2D or RP3D) — Approximately 12 months
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.

Trial sites (14)

Facility	City	Region	Status
University of California Irvine Medical Center	Orange	California	Not Yet Recruiting
BRCR Global	Coral Springs	Florida	Not Yet Recruiting
Florida Clinical Trials Group	Plantation	Florida	Not Yet Recruiting
START New Jersey	East Brunswick	New Jersey	Not Yet Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Not Yet Recruiting
START Mountain Region	West Valley City	Utah	Not Yet Recruiting
Beijing Cancer Hospital	Beijing	China	Recruiting
Jilin Cancer Hospital	Changchun	China	Not Yet Recruiting
Hunan Cancer Hospital	Changsha	China	Not Yet Recruiting
West China Hospital of Sichuan University	Chengdu	China	Not Yet Recruiting
The Sixth Affiliated Hospital,Sun Yat-sen University	Guangzhou	China	Recruiting
Shandong Cancer Hospital	Jinan	China	Recruiting
Jiangsu Province Hospital	Nanjing	China	Recruiting
Shanxi Provincial Cancer Hospitial	Taiyuan	China	Not Yet Recruiting

More Hutchmed trials in the USA

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

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor Recruiting

Other trials for the same condition

First In Human Study of CX-801 in Advanced Solid Tumors Recruiting

Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab Active, not recruiting

A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors Active, not recruiting

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Recruiting

A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07718581 on ClinicalTrials.gov ↗ ← All trials in the USA