Actively Recruiting
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
Led by Molecular Partners AG · Updated on 2026-05-22
138
Participants Needed
5
Research Sites
208 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
Researchers are evaluating the safety, tolerability, dosimetry, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of [212Pb]Pb-MP0712 in adults aged 18 years and older who have Small Cell Lung Cancer (SCLC) or other advanced tumors that express DLL3. This phase I/IIa, open-label, multi-center study includes patients with locally advanced or metastatic DLL3 positive tumors. The study is conducted by Molecular Partners AG and aims to determine appropriate dosing and assess early treatment activity in this patient group. The study has two parts: a dose escalation phase to find the recommended radioactive dose of [212Pb]Pb-MP0712, followed by a dose expansion phase to further assess safety, tolerability, and preliminary anti-tumor effects. Participants will first receive [203Pb]Pb-DOTAM-MAM279 for imaging and dosimetry purposes, then be treated with [212Pb]Pb-DOTAM-MAM279. The study includes monitoring of pharmacokinetics and imaging properties to better understand treatment distribution and effects. Participants will undergo regular safety assessments, blood tests, and imaging scans to monitor treatment effects and side effects. Researchers will evaluate safety events up to five years after treatment, measure drug concentrations, and track tumor response and progression during the 12-month dose expansion phase. Overall survival and duration of response will be followed for up to approximately five years, ensuring long-term monitoring of participants throughout the study duration.
CONDITIONS
Brief 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 Carcinoma (LC NEC) of the lung
- SCLC patients with progression or recurrence after at least two prior systemic platinum-based therapies and immunotherapy or not suitable/tolerating standard second-line treatment
- LC NEC lung patients with progression or recurrence after at least one prior systemic therapy
- Extrapulmonary neuroendocrine carcinomas (epNECs) with progression or recurrence after at least one prior systemic therapy, including gastroenteropancreatic NECs, cervical NECs, bladder NECs, or other epNECs with confirmed DLL3 expression
- Patients with prior DLL3-targeted therapy are allowed
- DLL3 positivity confirmed by [203Pb]Pb-DOTAM-MAM279 SPECT/CT for epNECs in Part 1 and Part 2 and for SCLC or LC NECs 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 based on blood and urine tests at screening
- Adequate blood counts: Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; White blood cells ≥2.5 x 10^9/L
- Adequate hepatic function
- Adequate renal function with GFR >60 mL/min (Cockroft-Gault formula)
- Clinically stable if known central nervous system metastases
You will not qualify if you...
- Uncontrolled intercurrent illness
- Patients without resolution of clinically significant toxic effects from prior cancer therapy, surgery, or radiotherapy to 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 except for specific exceptions
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 days following imaging agent administration
Participants receive [203Pb]Pb-DOTAM-MAM279 for imaging and dosimetry to confirm DLL3 expression and assess radiation absorption.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive [212Pb]Pb-DOTAM-MAM279 radioligand therapy to assess safety, tolerability, and preliminary anti-tumor activity.
Multiple treatment visits during each cycle
Duration - Up to approximately 5 years after last dose
Participants are monitored for safety, progression-free survival, duration of response, disease control, and overall survival after treatment ends.
Periodic visits over 5 years
Trial Site Locations
Total: 5 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
3
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
4
United Theranostics
Princeton, New Jersey, United States, 08540
Actively Recruiting
5
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Medical Director MPAG
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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