Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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