HMPL-A830 in Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More Hutchmed trials in China

Other trials for the same condition