A Phase 1 interventional study of PRT3645 in Breast Cancer, Glioblastoma and Head and Neck Squamous Cell Carcinoma, sponsored by Prelude Therapeutics. Completed at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Prelude Therapeutics · Phase 1, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 22 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Prelude Therapeutics is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:
Exclusion Criteria:
PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned
Drug: PRT3645
PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned
Dose limiting toxicity (DLT) of PRT3645
Dose limiting toxicity will be evaluated over the 28-day observation period
Time frame: Baseline through Day 28
Safety and tolerability of PRT3645: AEs, CTCAE Assessments
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame: Baseline through approximately 2 years
Maximally tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT3645
The MTD/RP2D will be established for further investigation in participants with advanced solid tumors
Time frame: Baseline through approximately 2 years
Efficacy of PRT3645: Tumor assessment and responses
Objective response rate (ORR), Progression-free survival (PFS), Disease control rate (DCR) and Duration of response (DOR) will use RECIST v1.1, mRECIST v1.1, and/or RANO as primary measure for tumor assessment and response.
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT3645: Minimum and maximum observed plasma concentration
PRT3645 pharmacokinetics will be calculated including the minimum and maximum observed plasma concentration.
Time frame: Baseline through approximately 2 years
Pharmacodynamic effect of PRT3645: Target engagement
Pharmacodynamic effect of PRT3645 demonstrating target engagement by assessment of phosphorylation of Rb.
Time frame: Baseline through approximately 2 years
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Prelude Therapeutics