Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMM-1-104 Monotherapy · 1 trial · 4 indications
Number of participants with adverse events
Number of participants with dose-limiting toxicities
Selection of candidate optimal dose to take forward into Ph2a
The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria
| Arm | Type | Description |
|---|---|---|
| IMM-1-104 monotherapy (Treatment Group A) | EXPERIMENTAL | IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer |
| IMM-1-104 in combination with mGnP (Treatment Group B) | EXPERIMENTAL | IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma |
| IMM-1-104 in combination with mFFX (Treatment Group C) | EXPERIMENTAL | IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma |
| IMM-1-104 in combination with dabrafenib (Treatment Group D) | EXPERIMENTAL | IMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation |
| IMM-1-104 in combination with pembrolizumab (Treatment Group E) | EXPERIMENTAL | IMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma |
| Name | Type | Description |
|---|---|---|
| IMM-1-104 Monotherapy (Treatment Group A) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles until treatment discontinuation criteria are met |
| IMM-1-104 + modified Gemcitabine/nab-Paclitaxel (Treatment Group B) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of gemcitabine and nab-paclitaxel until treatment discontinuation criteria are met. Gemcitabine will be administered at a dose of 1000 mg/m\^2 nab-Paclitaxel will be administered at a dose of 125 mg/m\^2 |
| IMM-1-104 + modified FOLFIRINOX (Treatment Group C) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of modified FOLFIRNOX until treatment discontinuation criteria are met. FOLFIRINOX will be administered as follows: Folinic Acid will be administered at 400 mg/m\^2 Fluorouracil will be administered at 2400 mg/m\^2 Irinotecan will be administered at 150 mg/m\^2 Oxaliplatin will be administered at 85 mg/m\^2 |
| IMM-1-104 + dabrafenib (Treatment Group D) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with twice daily oral dose of dabrafenib until treatment discontinuation criteria are met. Dabrafenib will be administered at a dose of 150mg daily (75mg twice daily). |
| IMM-1-104 + pembrolizumab (Treatment Group E) | DRUG | Once-daily, oral IMM-1-104 dose administered in 28-day cycles in combination with intravenous infusions of pembrolizumab in sequence or concurrently depending on the enrolled cohort (two sub cohorts) until treatment discontinuation criteria are met. Pembrolizumab will be administered at a dose of 400mg. |
Inclusion Criteria: * Must be ≥18 years of age * Must have histologically or cytologically confirmed diagnosis as follows: 1. Monotherapy Phase 1: A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation. 2. Monotherapy P...
| 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 |