Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FORX-428 · 1 trial · 1 indication
Adverse events will be recorded and severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
BOR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
ORR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
DCR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
PFS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
OS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Arm | Type | Description |
|---|---|---|
| First-in-human single-arm, open-label, multicenter Phase 1 dose escalation/expansion cohort study. | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| FORX-428 | DRUG | FORX-428 drug product is formulated as immediate release tablets for oral administration in 3 dosage strengths containing 10 mg, 50 mg, and 100 mg FORX-428 drug substance. |
Inclusion Criteria: 1. Patient must be \>/=18 years of age at time of signing informed consent; 2. Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors. 3. Patient must have progressed on at least 1 prior line of therapy in the advanced...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
FORX-428 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in patients with advanced solid tumors who have not responded to prior therapies.
FORX-428 is a PARG inhibitor, meaning it targets the enzyme poly(ADP-ribose) glycohydrolase (PARG). By inhibiting PARG, the drug is designed to interfere with DNA repair mechanisms in cancer cells, potentially leading to tumor cell death. This mechanism is being evaluated in patients with advanced solid tumors.
FORX-428 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of FORX-428 in patients with advanced solid tumors.
FORX-428 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.
FORX-428 is being studied in a single Phase 1 clinical trial with the identifier NCT07356453. This trial is titled "A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors" and is currently recruiting participants in the United States. The trial is uncontrolled and not randomized or blinded.
FORX-428 is a distinct investigational drug and is not known to be the same as any other approved medication. It is a PARG inhibitor being developed specifically for advanced solid tumors. No alternative names for FORX-428 have been reported in clinical trial registries.