NCT07718581

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_1

Timeline
39mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
2 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Dec 2029

First Submitted

Initial submission to the registry

July 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 24, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2029

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2.7 years

First QC Date

July 6, 2026

Last Update Submit

September 30, 2026

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Disease control rate (DCR)

    Approximately 2 years

  • Progression-free survival (PFS)

    Approximately 2 years

  • Pharmacokinetic Analysis(Cmax)

    Approximately 2 years

  • Pharmacokinetic Analysis (Cmin)

    Approximately 2 years

  • Pharmacokinetic Analysis(Tmax)

    Approximately 2 years

  • +3 more secondary outcomes

Study Arms (2)

Part A (Dose Escalation)

EXPERIMENTAL
Drug: HMPL-A830

Part B (Dose Optimization)

EXPERIMENTAL
Drug: HMPL-A830

Interventions

HMPL-A830DRUG

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

Part A (Dose Escalation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of California Irvine Medical Center

Orange, California, 92868, United States

NOT YET RECRUITING

BRCR Global

Coral Springs, Florida, 33065, United States

NOT YET RECRUITING

Florida Clinical Trials Group

Plantation, Florida, 33322, United States

NOT YET RECRUITING

START New Jersey

East Brunswick, New Jersey, 08816, United States

NOT YET RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 22, 2026

Study Start

September 24, 2026

Primary Completion (Estimated)

May 23, 2029

Study Completion (Estimated)

December 15, 2029

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)US(6)