A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients with DLL3 Expressing Tumors Including Small Cell Lung Cancer

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523438-24-00

Enrollment

Registered

2026-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DLL3 Expressing Tumors Including Small Cell Lung Cancer

Brief summary

Safety endpoints: incidence of DLT; incidence and severity of AEs/SAEs (graded based on CTCAE version 5.0); Efficacy endpoints: ORR, CR + PR and DOR per RECIST version 1.1 as assessed by the Investigator

Detailed description

Efficacy endpoints: objective response (ORR) and DOR per RECIST version 1.1 • Pharmacokinetic endpoints: blood concentrations and PK parameters of the ADC, total antibody (TAb), and unconjugated payload (IDC-0029701) • Immunogenicity endpoint: anti IDE849 antibody (antidrug antibody [ADA]) incidence and titer

Interventions

DRUGIDE849

DRUGIDE161

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety endpoints: incidence of DLT; incidence and severity of AEs/SAEs (graded based on CTCAE version 5.0); Efficacy endpoints: ORR, CR + PR and DOR per RECIST version 1.1 as assessed by the Investigator	—

Secondary

Measure	Time frame
Efficacy endpoints: objective response (ORR) and DOR per RECIST version 1.1 • Pharmacokinetic endpoints: blood concentrations and PK parameters of the ADC, total antibody (TAb), and unconjugated payload (IDC-0029701) • Immunogenicity endpoint: anti IDE849 antibody (antidrug antibody [ADA]) incidence and titer	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 4, 2026