Trials / Recruiting

RecruitingNCT07278479

Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors

A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 138 (estimated)

Sponsor: Molecular Partners AG · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[212Pb\]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3 positive tumors.

Detailed description

This is a phase I/IIa, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of \[212Pb\]Pb-MP0712 in patients with SCLC and other advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) \[212Pb\]Pb-MP0712 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of \[212Pb\]Pb-MP0712. The study will enable evaluation of the safety, dosimetry, PK, and imaging properties of \[203Pb\]Pb-MP0712.

Conditions

Interventions

Type	Name	Description
DRUG	[212Pb]Pb-MP0712	Radioligand Therapy
OTHER	[203Pb]Pb-MP0712	Radioligand Imaging Agent

Timeline

Start date: 2026-04-01
Primary completion: 2028-09-01
Completion: 2032-09-01
First posted: 2025-12-12
Last updated: 2026-04-08

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07278479. Inclusion in this directory is not an endorsement.