A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIDEAYA Biosciences
About this trial
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.
Eligibility criteria
Qualifiers
Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.
Subjects with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment.
Subjects with NEC, this includes
High-grade gastroenteropancreatic NEC
Disqualifiers
Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are ineligible.
Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.
Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after curative therapy with no recurrence, or papillary thyroid cancer after curative resection; other prior or concurrent malignancies may be eligible with Medical Monitor review and approval.
Have uncontrolled tumor-associated pain.
Trial design
Treatments tested in this trial
- IDE849
- durvalumab
- IDE161
- Carboplatin
Treatment groups
262 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov