Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07278479

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

Led by Molecular Partners AG · Updated on 2026-04-08

138

Participants Needed

3

Research Sites

335 weeks

Total Duration

On this page

Sponsors

M

Molecular Partners AG

Lead Sponsor

O

Orano Med LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed advanced extensive or limited Small Cell Lung Cancer (SCLC) or large cell neuroendocrine carcinomas (LCNECs) of the lung
  • For SCLC: progression or recurrence after at least two prior lines of platinum-based systemic therapy and immunotherapy, or not suitable for or tolerating standard second-line therapy
  • For LCNEC of the lung: progression or recurrence after at least one prior line of systemic therapy
  • Extrapulmonary neuroendocrine carcinomas (epNECs) with progression or recurrence after at least one prior line of systemic therapy, including gastroenteropancreatic NECs, cervical NECs, bladder NECs, or other epNECs with confirmed DLL3 expression by immunohistochemistry
  • Prior DLL3-targeted therapy allowed
  • DLL3 positivity confirmed by [203Pb]Pb-DOTAM-MAM279 SPECT/CT for epNECs in parts 1 and 2 and for SCLC or LCNECs in part 2
  • Radiographically documented disease progression or recurrence during or after last systemic therapy
  • At least one measurable disease per RECIST v1.1
  • Adequate bone marrow reserve and organ function with specified blood counts and biochemistry
  • Adequate hepatic and renal function (calculated glomerular filtration rate >60 mL/min)
  • Clinically stable patients with known central nervous system metastasis eligible
Not Eligible

You will not qualify if you...

  • Uncontrolled intercurrent illness
  • Unresolved clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy above grade 1 (except grade 2 alopecia or stable grade 2 sensory neuropathy)
  • 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
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

United Theranostics

Glen Burnie, Maryland, United States, 21061

Actively Recruiting

2

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Actively Recruiting

3

United Theranostics

Princeton, New Jersey, United States, 08540

Actively Recruiting

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Research Team

M

Medical Director MPAG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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