Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GI-101 · 1 trial · 6 indications
Dose escalation and optimization phase of Part A, B, and C and Dose escalation phase of Part E and F
Based on Central review (Part G1) and Investigator review (Part G2) of radiographic imaging in Part G1 Dose optimization cohorts, Part G2 Indication-specific cohorts ORR only; Based on Investigator review of radiographic imaging in dose expansion phase of Part A, B and C
| Arm | Type | Description |
|---|---|---|
| GI-101 | EXPERIMENTAL | Dose escalation: GI-101, multiple ascending doses Dose expansion: |
| GI-101 + Pembrolizumab | EXPERIMENTAL | Dose escalation: GI-101, multiple ascending doses Dose expansion: |
| GI-101 + Lenvatinib | EXPERIMENTAL | Dose optimization: Dose expansion: |
| GI-101A | EXPERIMENTAL | Dose escalation: GI-101A, multiple ascending doses |
| GI-101A + Pembrolizumab | EXPERIMENTAL | Dose escalation: GI-101A, multiple ascending doses Dose optimization Indication-specific cohorts |
| Name | Type | Description |
|---|---|---|
| GI-101 | DRUG | Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years). |
| Pembrolizumab (KEYTRUDA®) | DRUG | Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W. |
| Lenvatinib | DRUG | Lenvatinib will be administered at an approved dose orally. |
| GI-101A | DRUG | Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years). |
Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening. * Has adequate organ and marrow function as defined in protocol. * Measurable disease as per RECIST v1.1. * ECOG performance status 0-1. * Adverse events re...
| 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 |
GI-101 is an investigational small molecule being studied for the treatment of advanced solid tumors, including metastatic solid tumors, cervical cancer, urothelial carcinoma, clear cell renal cell cancer (ccRCC), and squamous cell non-small cell lung cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
GI-101 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials for advanced solid tumors.
GI-101 is in Phase 1 clinical development. It is an investigational drug being studied in a single active clinical trial for advanced solid tumors. The drug has not been approved by the FDA and remains in early-stage clinical testing.
GI-101 is being studied in one active clinical trial, NCT04977453, which evaluates GI-101 as a single agent or in combination with pembrolizumab or lenvatinib in advanced solid tumors. The trial is recruiting participants in the United States and South Korea, with an enrollment of 317 patients.
Yes, GI-101 is also referred to as GI-101A in clinical trial documentation. The trial NCT04977453 is titled 'GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors,' indicating that both names refer to the same investigational drug.