A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer

Conditions

• Neuroendocrine Carcinomas
• Small-cell Lung Cancer
• Solid Tumor Show to Express DLL3

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IDE849 — DRUG
  IV administration
• durvalumab — DRUG
  IV administration
• IDE161 — DRUG
  oral administration

Study Details

This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.

Key Dates

Start date

Oct 14, 2025

Status verified

Jan 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

208 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental: Part 1A IDE849 Monotherapy (Dose Escalation)
  Successive cohorts of participants will be treated with escalating doses of IDE849 until the maximum tolerated dose and dose for expansion are determined
• Experimental: Experimental: Part 1B IDE849 + durvalumab (Dose Escalation)
  Multiple doses of IDE849 will be tested in combination with durvalumab to identify the optimal combination dose.
• Experimental: Experimental: Part 1B IDE849 + IDE161 (Dose Escalation)
  Multiple doses of IDE849 will be tested in combination with IDE161 to identify the optimal combination dose.
• Experimental: Experimental: Part 2 IDE849 Monotherapy (Dose Expansion)
  Chosen monotherapy doses of IDE849 will be tested in additional participants.
• Experimental: Experimental: Part 2 IDE849 + durvalumab (Dose Expansion)
  Chose combination dose of IDE849 + durvalumab will be tested in additional participants.
• Experimental: Experimental: Part 2 IDE849 + IDE161 (Dose Expansion)
  Chose combination dose of IDE849 + IDE161 will be testing in additional participants

Primary Outcome Measure

Part 1A: Safety and Tolerability of IDE849 (Monotherapy) [ Time Frame: approximately 4 years total study duration ]

Central Contacts

• IDEAYA Clinical Trials
  +1-855-433-2246
  [email protected]

Locations (20)

Find similar trials in Denver, CO

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