UnknownPhase 1

Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT

China113 participantsStarted 2022-01-18

Plain-language summary

To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Able to understand and willing to sign the ICF.
✓. Aged 18 to 75 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Life expectancy at least 12 weeks.
✓. Adequate bone marrow, liver and kidney function.

Exclusion criteria

✕. Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
✕. Previous treatment with anti-CSF1R therapy and have progressive disease;
✕. Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
✕. Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
✕. Pregnant or lactating women.

What they're measuring

Occurrence of Dose-Limiting Toxicities(DLTs)

Timeframe: up to 33 days

Maximum tolerated dose (MTD)

Timeframe: up to 12 months

Recommended phase II dose (RP2D)

Timeframe: up to 12 months

Trial details

NCT IDNCT05277454

SponsorHutchison Medipharma Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-28

Contact for this trial

Cindy Hua

+86 21 2067 3221 cindyh@hutch-med.com

View on ClinicalTrials.gov More Advanced Malignant Solid Tumors trials