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A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy: 1.
HR+ and HER2- or HR+ and HER2+ breast cancer. 2. Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mutant astrocytoma. 3. KRAS-mutant or SMARCA4 loss NSCLC. 4. 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. 5. 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.

Exclusion Criteria:

  • - Participants with advanced, symptomatic, extensive visceral disease.
  • - Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, any upper gastrointestinal surgery including gastric resection, known malabsorption syndrome, or other condition that may impair absorption of PRT3645.
  • - Treatment with strong inhibitors of CYP3A4.
  • - History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study.
  • - Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM.
  • - Endometrial cancer patients who had received prior treatment with a CDK 4/6 inhibitor.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05538572
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prelude Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Singapore, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, Glioblastoma, Head and Neck Squamous Cell Carcinoma, Malignant Mesothelioma, Non-small Cell Lung Cancers, Sarcoma, Endometrial Cancer
Additional Details

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.

Arms & Interventions

Arms

Experimental: PRT3645

PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned

Interventions

Drug: - PRT3645

PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Smilow Cancer Hospital Phase 1 Unit, New Haven, Connecticut

Status

Address

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, 06511

Celebration, Florida

Status

Address

AdventHealth Medical Group Oncology Research at Celebration

Celebration, Florida, 34747

Miami Cancer Institute, Miami, Florida

Status

Address

Miami Cancer Institute

Miami, Florida, 33176

Florida Cancer Specialists, Sarasota, Florida

Status

Address

Florida Cancer Specialists

Sarasota, Florida, 34232

Atlanta, Georgia

Status

Address

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

New York, New York

Status

Address

Laura and Isaac Perlmutter Cancer Center/ NYU Langone Health

New York, New York, 10016

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Philadelphia, Pennsylvania

Status

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

Tennessee Oncology, PLLC, Nashville, Tennessee

Status

Address

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

San Antonio, Texas

Status

Address

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229

NEXT Virginia, Fairfax, Virginia

Status

Address

NEXT Virginia

Fairfax, Virginia, 22031

International Sites

National Cancer Centre Singapore, Singapore, Singapore

Status

Address

National Cancer Centre Singapore

Singapore, , 168583