FORX-428 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced solid tumors that have BRCA1/2 mutations or other DNA repair deficiencies. They must have tried at least one standard treatment and show measurable disease progression. Specific cohorts include those with breast or ovarian cancer who've had certain treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of FORX-428 to determine the maximum tolerated dose and Recommended Cohort Expansion Dose
Dose Expansion
Participants receive the Recommended Cohort Expansion Dose of FORX-428 to evaluate preliminary anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FORX-428
Trial Overview
FORX-428, a PARG inhibitor, is being tested to see how safe it is and what the highest dose patients can take without serious side effects (MTD) in people with specific genetic alterations related to their tumor's ability to repair DNA damage.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
FORX 428 dose levels planned in the study: Dose Level 1: 30 mg, daily; Dose Level 2: 60 mg, daily; Dose Level 3: 120 mg, daily; Dose Level 4: 200 mg, daily; Dose Level 5: 300 mg, daily; and Dose Level 6: 400 mg, daily. Following the selection of the Recommended Cohort Expansion Dose during Part 1 of the study, new patients will be included in 3 cohorts, with simultaneous parallel enrollment. Patients will be allowed to continue to receive FORX-428 monotherapy until disease progression or unacceptable toxicity. Part 2 will include approximately up to 29 evaluable patients in each expansion cohort as determined by the Simon's optimal 2-stage design. In Stage 1 of each cohort of Part 2, a total number of 10 patients will be accrued. If there are 1 or fewer responses by RECIST version 1.1 among these 10 patients, further enrollment in that cohort will be halted for futility. Otherwise, an additional 19 patients will be accrued per cohort in Stage 2 of Part 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FoRx Therapeutics AG
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.