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

HUTCHMED

Status and phase: Enrolling; Phase 1

Conditions: TGCT; Advanced Malignant Solid Tumors

Treatments: Drug: HMPL-653

Study type: Interventional

Funder types: Industry

Identifiers

NCT05277454

2021-653-00CH1

Details and patient eligibility

About

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.

Enrollment: 113 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

113 participants in 1 patient group

HMPL-653 open-label treatment arm

Experimental group

Description:

Dose-escalation Stage: Participants will be treated with escalating doses of HMPL-653 to determine the MTD and RP2D. Dose-expansion Stage: Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of HMPL-653 in TGCT and specific advanced solid tumors.

Treatment:

Drug: HMPL-653