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

NCT ID: NCT07278479

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2032-09-30

Brief 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

Large Cell Neuroendocrine Carcinoma; Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC); Extrapulmonary Neuroendocrine Carcinoma (EP-NEC); Small Cell Lung Cancer (SCLC); Gastroenteropancreatic NEC (GEP NEC); NEC of the Bladder; Other DLL3 Expressing epNEC

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[203Pb]Pb-DOTAM-MAM279/[212Pb]Pb-DOTAM-MAM279

Patients will receive \[203Pb\]Pb-DOTAM-MAM279 for Imaging/Dosimetry followed by \[212Pb\]Pb-DOTAM-MAM279 for treatment

Group Type: EXPERIMENTAL

[212Pb]Pb-MP0712

Intervention Type: DRUG

Radioligand Therapy

[203Pb]Pb-MP0712

Intervention Type: OTHER

Radioligand Imaging Agent

Interventions

[212Pb]Pb-MP0712

Radioligand Therapy

Intervention Type: DRUG

[203Pb]Pb-MP0712

Radioligand Imaging Agent

Intervention Type: OTHER

Other Intervention Names

[212Pb]Pb-DOTAM-MAM279; [203Pb]Pb-DOTAM-MAM279

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Histologically or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung

• SCLC (extensive stage, or limited stage) patients with progression or recurrence following at least two prior line of systemic platinum based therapy and immunotherapy or are not suitable or tolerating the standard of care treatment as second line of systemic therapy, or
• LC NEC of the lung patients with progression or recurrence following at least one prior line of systemic therapy, or II. epNECs with progression or recurrence following at least one prior line of systemic therapy:
• Gastroenteropancreatic NECs (GEPNEC), or
• Cervical NECs, or
• Bladder NECs, or
• other epNECs with previously confirmed DLL3 expression by IHC.
• Patients with prior DLL3-targeted therapy are allowed.
• For epNECs in Part 1 and Part 2 and SCLC or LC NECs of the lung in Part 2: DLL3-positivity by [203Pb]Pb-DOTAM-MAM279 SPECT/CT
• Radiographically documented disease progression or recurrence during or after the last line of systemic treatment therapy
• At least one measurable disease per RECIST v1.1.
• Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening
• Adequate blood counts: Hemoglobin ≥9 g/dL; Absolute neutrophil count (ANC) ≥1.5 × 10^9/L; Platelets ≥100 × 10^9/L; White blood cells (WBC) ≥2.5 x 10^9/L;
• Adequate hepatic function
• Adequate renal function: Calculated glomerular filtration rate (GFR) >60mL/min (using Cockroft-Gault formula).
• Patients with known central nervous system (CNS) metastasis will be eligible if they are clinically stable.

Exclusion Criteria

• Uncontrolled intercurrent illness
• Patients who have not had resolution of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for grade ≤2 alopecia, or stable grade 2 sensory neuropathy, according to the last CTCAE version).
• Active clinically significant cardiac disease
• Evidence of interstitial lung disease or active, non-infectious pneumonitis.
• History of other malignancy within the past 2 years with exceptions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orano Med LLC

INDUSTRY

Sponsor Role: collaborator

Molecular Partners AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Medical Director MPAG

Role: CONTACT

info@molecularpartners.com

+41 44 755 77 00

Facility Contacts

Research Director

Role: primary

clinicaltrials@nebraskacancer.com

402-955-2691

Other Identifiers

MP0712-CP101

Identifier Type: -

Identifier Source: org_study_id