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
No
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 (7)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
China
Hunan Cancer Hospital
Changsha
China
West China Hospital of Sichuan University
Chengdu
China
The Sixth Affiliated Hospital,Sun Yat-sen University
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.
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