Approval Probability
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GEN1119 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part 1): GEN1119 | EXPERIMENTAL | Participants will receive a number of dose levels (DLs) of GEN1119. |
| Dose Refinement (Part 2): GEN1119 | EXPERIMENTAL | Participants will be randomized to receive a number of DLs of GEN1119. |
| Expansion (Part 3): GEN1119 | EXPERIMENTAL | Participants with certain solid tumours will receive GEN1119 at the recommended expansion dose(s) as defined in Parts 1 and/or 2. |
| Name | Type | Description |
|---|---|---|
| GEN1119 | DRUG | Administered at certain DLs on specified days. |
Key Inclusion Criteria: * Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours. * Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
GEN1119 is an investigational small molecule developed by Genmab A/S for the treatment of solid tumours. It is in Phase 1 clinical development and has not been approved for any indication. Genmab is conducting a single active trial of GEN1119 in participants with solid tumors.
GEN1119 is being studied as a treatment for solid tumours, a broad group of cancers affecting tissues outside the blood. It is an investigational therapy and is not approved for use in solid tumours or any other indication. Its only active trial is enrolling adults with solid tumors.
GEN1119 is developed by Genmab A/S, a biotechnology company listed under the ticker GMAB. Genmab is the sponsor of the Phase 1 trial evaluating GEN1119 in participants with solid tumors. No other developer is associated with the asset in the available trial record.
GEN1119 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency. The Phase 1 program consists of one recruiting trial with a planned enrollment of 112 participants. Phase 1 studies primarily assess safety, tolerability, and early activity.
GEN1119 is being evaluated in one active clinical trial, NCT07695831, titled A Phase 1 Trial of GEN1119 in Participants With Solid Tumors. The trial is currently recruiting, has a planned enrollment of 112 participants, and is controlled and randomized. It is open to adults aged 18 years and older of all sexes and is running in France, Japan, and Spain.