Trials / Completed
CompletedNCT05538572
A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Prelude Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and recommended phase 2 dose to be used in subsequent development of PRT3645.
Detailed description
This is an open-label, multicenter, dose-escalation Phase 1 study of PRT3645, a CDK4/6 inhibitor, evaluating patients with selected advanced or metastatic solid tumors including breast cancer (BC), glioblastoma (GBM), non-small cell lung cancer (NSCLC), sarcomas, head and neck squamous cell carcinoma (HNSCC), malignant mesothelioma, and endometrial cancer. The study plan expects to evaluate approximately eight dose levels however additional dose levels may be explored. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. Up to 15 patients may be enrolled at a dose shown to be tolerated for confirmation of the MTD and/or RP2D.
Conditions
- Breast Cancer
- Glioblastoma
- Head and Neck Squamous Cell Carcinoma
- Malignant Mesothelioma
- Non-small Cell Lung Cancers
- Sarcoma
- Endometrial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRT3645 | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
Timeline
- Start date
- 2022-12-27
- Primary completion
- 2024-06-26
- Completion
- 2024-06-26
- First posted
- 2022-09-14
- Last updated
- 2024-07-01
Locations
13 sites across 2 countries: United States, Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05538572. Inclusion in this directory is not an endorsement.