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...
Top 20 of 90 competitors
IDE849 is an investigational small molecule developed by IDEAYA Biosciences, Inc. (ticker IDYA) for DLL3 expressing tumors, including small-cell lung cancer. It is in Phase 1 clinical development and is being studied in a single recruiting trial in the United States. It has not been approved by the FDA.
IDE849 is being evaluated for the treatment of DLL3 expressing tumors, including small-cell lung cancer, as well as neuroendocrine carcinomas and other solid tumors shown to express DLL3. It is an investigational therapy in Phase 1 testing and is not approved for any indication.
IDE849 targets DLL3, a protein expressed on the surface of certain tumor cells. By binding DLL3, the small molecule is designed to act on tumors that express this target. The Phase 1 trial enrolls patients whose tumors are selected for DLL3 expression.
IDE849 is being developed by IDEAYA Biosciences, Inc., which trades on the Nasdaq under the ticker IDYA. The company is running the Phase 1 study of IDE849 in the United States.
IDE849 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants and is designed to enroll 262 patients.
IDE849 is being studied in the Phase 1 trial NCT07174583, titled A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer. The trial is recruiting in the United States, enrolls adults 18 years and older of all sexes, and has a controlled design.