Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FOG-001 · 1 trial · 15 indications
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
Incidence of DLTs
The rate of objective responses (Partial \& Complete) using RECIST v1.1
The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1
The response to treatment as a 30% or greater reduction in PSA levels from baseline
| Arm | Type | Description |
|---|---|---|
| Part 1a | EXPERIMENTAL | Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status |
| Part 1b | EXPERIMENTAL | MSS CRC (known WPAM negative participants are not eligible) |
| Part 1c | EXPERIMENTAL | Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required) |
| Part 1d-1 | EXPERIMENTAL | Desmoid Tumors |
| Part 1d-2 | EXPERIMENTAL | Desmoid Tumors |
| Part 1f-1 | EXPERIMENTAL | MSS CRC (known WPAM negative participants are not eligible) |
| Part 1f-2 | EXPERIMENTAL | Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible) |
| Part 1f-3 | EXPERIMENTAL | MSS CRC (known WPAM negative participants are not eligible) |
| Part 1g | EXPERIMENTAL | Solid Tumors with documented WPAM (known WPAM negative participants are not eligible) |
| Part 1h | EXPERIMENTAL | Desmoid Tumors |
| Part 1i | EXPERIMENTAL | Familial adenomatous polyposis (FAP) |
| Part 2a | EXPERIMENTAL | MSS CRC, irrespective of WPAM status |
| Part 2b | EXPERIMENTAL | Solid Tumors with documented WPAM |
| Part 2c | EXPERIMENTAL | Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required) |
| Part 2d | EXPERIMENTAL | Desmoid Tumors |
| Part 2e | EXPERIMENTAL | Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required) |
| Part 2f-1 | EXPERIMENTAL | MSS CRC (known WPAM negative participants are not eligible) |
| Part 2f-2 | EXPERIMENTAL | Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible) |
| Part 2f-3 | EXPERIMENTAL | MSS CRC (known WPAM negative participants are not eligible) |
| Name | Type | Description |
|---|---|---|
| FOG-001 | DRUG | FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days |
| mFOLFOX-6 | DRUG | mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001 |
| Nivolumab | DRUG | Nivolumab will be administered per the prescribing information in combination with FOG-001 |
| Trifluridine/tipiracil | DRUG | Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001 |
| Bevacizumab | DRUG | Bevacizumab will be administered per the prescribing information in combination with FOG-001 |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ and marrow function. Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1g): * Diagnosis of treatment-refractory advanced/metastatic solid tumor that is non-MSI-...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | Durvalumab |
| Nanobiotix SA Sponsored ADR | NBTX | 1 | PHASE1 | NBTXR3 |
| Olema Pharmaceuticals, Inc. | OLMA | 1 | PHASE1 | OP-3136, Palazestrant |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
| Pfizer Inc. | PFE | 1 | N/A | Palbociclib |