A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
Brain & Spinal Cord Tumor
Lung Cancer
Sarcoma
18 Years and older, Male and Female
PRT3645-01 (primary)
NCI-2022-09871
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.
Objectives
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.
Eligibility
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:
- HR+ and HER2- or HR+ and HER2+ breast cancer
- Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mutant astrocytoma
- KRAS-mutant or SMARCA4 loss NSCLC
- CDK pathway alternation in any of the following tumor types: malignant mesothelioma, HPV-negative HNSCC (including oral cavity, oropharynx, hypopharynx, and larynx), sarcoma, or NSCLC
- Estrogen receptor positive with TP53 wild type endometrial cancer
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- Must have measurable or non-measureable (but evaluable) disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) =80% (KPS is for GBM only)
- Adequate organ function.
- Able to swallow and retain oral medication.
- Must provide either archival or fresh tumor tissue sample during screening.
Treatment Sites in Georgia
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