Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07174583 | A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer | PHASE1 | RECRUITING | 208 | — | — | Oct 14, 2025 | May 1, 2029 | Jan 23, 2026 | 39 | United States, Australia +5 |
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 |
|---|---|---|
| Experimental: 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 |
| Experimental: Part 1B IDE849 + durvalumab (Dose Escalation) | EXPERIMENTAL | Multiple doses of IDE849 will be tested in combination with durvalumab to identify the optimal combination dose. |
| Experimental: Part 1B IDE849 + IDE161 (Dose Escalation) | EXPERIMENTAL | Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose. |
| Experimental: Part 2 IDE849 Monotherapy (Dose Expansion) | EXPERIMENTAL | Chosen monotherapy doses of IDE849 will be tested in additional participants. |
| Experimental: Part 2 IDE849 + durvalumab (Dose Expansion) | EXPERIMENTAL | Chose combination dose of IDE849 + durvalumab will be tested in additional participants. |
| Experimental: Part 2 IDE849 + IDE161 (Dose Expansion) | EXPERIMENTAL | Chose 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 |
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 extensive-stage SCLC neuroendocrine carcinoma (NEC), and other DLL3+ tumors, are eligible per p...