Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDE849 · 1 trial · 3 indications
Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.
Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.
Incidence and severity and relationship of AEs and SAEs as measured by CTCAE V5.0
Incidence and severity and relationship of AEs and SAEs graded as measured by CTCAE V 5.0.
ORR per RECIST v1.1, defined as the proportion of subjects with a Complete Response (CR) or Partial Response (PR) as assessed by the Investigator.
DOR per RECIST v1.1, defined as the time from the first documented Complete Response (CR) or Partial Response (PR) to disease progression or death, whichever occurs first, as assessed by the Investigator.
| Arm | Type | Description |
|---|---|---|
| Part 1A IDE849 Monotherapy (Dose Escalation) | EXPERIMENTAL | Successive cohorts of participants will be treated with escalating doses of IDE849 until the maximum tolerated dose and dose for expansion are determined |
| Part 1B IDE849 + durvalumab, or IDE849 + durvalumab + carboplatin (Dose Escalation) | EXPERIMENTAL | Multiple doses of IDE849 will be tested in combination with durvalumab or in combination with durvalumab + carboplatin to identify the optimal combination dose. |
| Part 1B IDE849 + IDE161 (Dose Escalation) | EXPERIMENTAL | Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose. |
| Part 2 IDE849 Monotherapy RDE 1 for SCLC (Dose Expansion) | EXPERIMENTAL | Chosen monotherapy doses of IDE849 will be tested in additional participants. |
| Part 2 IDE849 Monotherapy RDE 2 for SCLC (Dose Expansion) | EXPERIMENTAL | Chosen monotherapy doses of IDE849 will be tested in additional participants |
| Part 2 IDE849 Monotherapy for NEC (Dose Expansion) | EXPERIMENTAL | Chosen monotherapy doses of IDE849 will be tested in additional participants. |
| Part 2 IDE849 + durvalumab (Dose Expansion) | EXPERIMENTAL | Chosen combination dose of IDE849 + durvalumab will be tested in additional participants. |
| Part 2 IDE849 + durvalumab + carboplatin (Dose Expansion) | EXPERIMENTAL | Chosen combination dose of IDE849 + durvalumab + carboplatin will be tested in additional participants. |
| Part 2 IDE849 + IDE161 (Dose Expansion) | EXPERIMENTAL | Chosen combination dose of IDE849 + IDE161 will be testing in additional participants |
| Name | Type | Description |
|---|---|---|
| IDE849 | DRUG | IV administration |
| durvalumab | DRUG | IV administration |
| IDE161 | DRUG | oral administration |
| Carboplatin | DRUG | IV administration |
Inclusion Criteria: 1. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF. 2. Subjects with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. Subjec...
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IDE849 is an investigational small molecule being developed for the treatment of small-cell lung cancer and other DLL3-expressing tumors, including neuroendocrine carcinomas and solid tumors. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
IDE849 targets DLL3, a protein expressed on the surface of certain tumor cells, including those in small-cell lung cancer. By targeting DLL3, the drug aims to interfere with tumor growth in cancers that express this protein.
IDE849 is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IDYA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with DLL3-expressing tumors.
IDE849 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in patients with DLL3-expressing tumors.
IDE849 is being studied in a Phase 1 clinical trial with the identifier NCT07174583. This trial is recruiting patients with DLL3-expressing tumors, including small-cell lung cancer, neuroendocrine carcinomas, and solid tumors, and is being conducted in the United States.
IDE849 is a distinct investigational small molecule that targets DLL3. While other drugs may also target DLL3, IDE849 is a separate asset developed by IDEAYA Biosciences. It is currently in early-stage clinical trials and has not been compared directly to other DLL3-targeting therapies in published data.