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New treatment option for Advanced Solid Tumors
Official title A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT07356453
What this study is testing
What is FORX-428?
FORX-428 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-48 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 as monotherapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be \>/=18 years of age at time of signing informed consent;
- Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors.
- Patient must have progressed on at least 1 prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of...
- Patient must fulfill genomic selection criteria: prior available documented evidence in tissue or blood (circulating tumor DNA [ctDNA]) of the...
- Patients with BRCA1/2 mutations (germline or somatic, pathogenic or likely pathogenic) and other mutations signifying HR deficiency or high...
You likely can't join if
- Patient has received anti-cancer treatment or an investigational agent \</=14 days or 5 half-lives prior to first dose, whichever is shorter, or...
- Patient has had previous exposure to a PARG inhibitor;
- Patient has a history of other malignancy diagnosed \ 2 years at the time of consent and includes the following: completely resected cervical...
- Patient has had major surgery within 30 days prior to first dose of study drug (with exceptions further defined in the protocol), or anticipation of...
- Patient has impaired cardiovascular function or clinically significant cardiovascular disease as further stipulated in the protocol;
- Patient has uncontrolled HIV or hepatitis C infection;
See the full eligibility criteria
- Patient must be \>/=18 years of age at time of signing informed consent;
- Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors.
- Patient must have progressed on at least 1 prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care. In general, if maintenance therapy is part of the standard of...
- Patient must fulfill genomic selection criteria: prior available documented evidence in tissue or blood (circulating tumor DNA [ctDNA]) of the genetic alterations indicated below. The Sponsor Medical Monitor or delegate...
- Patients with BRCA1/2 mutations (germline or somatic, pathogenic or likely pathogenic) and other mutations signifying HR deficiency or high replication stress.
- For Dose Expansion: Tumor types for Dose Expansion cohorts include a subset of tumors specified in Inclusion Criterion 3 as follows: i) Cohort 1: Advanced or metastatic breast cancer independent of hormone receptor...
- United States (US): Testing must have been performed using a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA)-certified laboratory developed test (LDT) or a Food and Drug...
- Patient has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Clinical Screening; Note: Tumor lesions situated in a previously irradiated or otherwise locally treated...
- Patient has adequate bone marrow and organ function, defined by the following laboratory results obtained within 14 days before first dose of study drug:
- Platelet count \>/=100 × 10\^9/L (\>/=100,000/μL) (absence of platelet transfusion within 1 week);
- Hemoglobin \>/=90 g/L (\>/=5.6 mmol/L) (absence of red blood cell transfusion within 2 weeks);
- Absolute neutrophil count \>/=1.5 × 10\^9/L (\>/=1500/μL) (absence of growth factors within 2 weeks);
- Aspartate aminotransferase and alanine aminotransferase \</=2.5 × upper limit normal (ULN) or \</=5 × ULN for patients with liver metastases;
- Total bilirubin \</=1.5 × ULN, or \</=3.0 × ULN for patients with liver metastases or Gilbert's syndrome;
- Estimated glomerular filtration rate \>/=60 mL/min calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration Equation; and
- Adequate coagulation test results defined by activated partial thromboplastin time \</=1.5 × ULN, international normalized ratio (INR) \</=2.0 with the exception of INR 2 to 3 acceptable for patients on warfarin...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 with \>/=3 months of life expectancy for Dose Escalation cohorts, and an ECOG PS of 0 to 1 with \>/=3 months of life...
- Patient is able to swallow tablets and has no gastrointestinal conditions affecting absorption.
- Patient has received anti-cancer treatment or an investigational agent \</=14 days or 5 half-lives prior to first dose, whichever is shorter, or patient has received immunotherapy \</=28 days prior to first dose; Note...
- Patient has had previous exposure to a PARG inhibitor;
- Patient has a history of other malignancy diagnosed \ 2 years at the time of consent and includes the following: completely resected cervical carcinoma in situ, basal or squamous cell skin cancer, ductal carcinoma in...
- Patient has had major surgery within 30 days prior to first dose of study drug (with exceptions further defined in the protocol), or anticipation of major surgery during study treatment;
- Patient has impaired cardiovascular function or clinically significant cardiovascular disease as further stipulated in the protocol;
- Patient has uncontrolled HIV or hepatitis C infection;
- Patient has known metastatic central nervous system malignant disease or leptomeningeal disease; Note: Patients previously treated for brain metastasis who are asymptomatic, receiving \</=10 mg/day prednisone...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- San Francisco, California, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; San Francisco, California, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; Portland, Oregon, United States; Houston, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.