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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
IDE849
DrugIV administration
durvalumab
DrugIV administration
IDE161
Drugoral administration
Carboplatin
DrugIV administration
Treatment groups
262 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Part 1A IDE849 Monotherapy (Dose Escalation)Experimental treatment 1 intervention
Group B: Part 1B IDE849 + durvalumab, or IDE849 + durvalumab + carboplatin (Dose Escalation)Experimental treatment 3 interventions
Group C: Part 1B IDE849 + IDE161 (Dose Escalation)Experimental treatment 2 interventions
Group D: Part 2 IDE849 Monotherapy RDE 1 for SCLC (Dose Expansion)Experimental treatment 1 intervention
Group E: Part 2 IDE849 Monotherapy RDE 2 for SCLC (Dose Expansion)Experimental treatment 1 intervention
Group F: Part 2 IDE849 Monotherapy for NEC (Dose Expansion)Experimental treatment 1 intervention
Group G: Part 2 IDE849 + durvalumab (Dose Expansion)Experimental treatment 2 interventions
Group H: Part 2 IDE849 + durvalumab + carboplatin (Dose Expansion)Experimental treatment 3 interventions
Group I: Part 2 IDE849 + IDE161 (Dose Expansion)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part 1A: Safety and Tolerability of IDE849 (Monotherapy)
Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.
Time frame
approximately 4 years total study duration2
Part 1B: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161
Incidence of dose-limiting toxicities, incidence and severity AEs and SAEs as measured by CTCAE V5.0.
Time frame
approximately 4 years total study duration3
Part 2: Safety and Tolerability of IDE849 (Monotherapy Dose Expansion)
Incidence and severity and relationship of AEs and SAEs as measured by CTCAE V5.0
Time frame
approximately 4 years total study duration4
Part 2: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161 or durvalumab + carboplatin (Dose Expansion)
Incidence and severity and relationship of AEs and SAEs graded as measured by CTCAE V 5.0.
Time frame
approximately 4 years total study durationSecondary outcomes
1
Part 1 and Part 2: Disease Control Rate (DCR) and Investigator Assessment of IDE849 DCR per RECIST 1.
Time frame
approximately 4 years total study duration2
Part 2: Progression-Free Survival (PFS) PFS per RECIST1.1 PFS per RECIST1.1.
Time frame
approximately 4 years total study duration3
Part 2: Overall Survival (OS)
Overall Survival (OS) defined as the time from first dose of IDE849 to death due to any cause
Time frame
approximately 4 years total study duration4
Part 1 and Part 2: Pharmacokinetics (PK) of IDE849 and in combination with durvalumab, durvalumab + carboplatin, and IDE161 Blood concentrations and PK parameters.
Time frame
approximately 4 years total study durationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov