Clinical trial · Interventional
Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-653 in Treatment of Patients With Advanced Malignant Solid Tumors and Tenosynovial Giant Cell Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| TGCT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-653 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HMPL-653 open-label treatment arm
- 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.
- interventionNames
- Drug: HMPL-653
Primary outcomes (3)
- measure
- Occurrence of Dose-Limiting Toxicities(DLTs)
- timeFrame
- up to 33 days
- description
- To evaluate the safety and tolerability of HMPL-653 for dose escalation period
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available