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Study of [212Pb]Pb-MP0712 for Small Cell Lung Cancer and Other DLL3 Expressing Tumors

This study is testing a new treatment called [212Pb]Pb-MP0712, which is a type of radioligand therapy. It's designed to target and treat certain cancers, including small cell lung cancer (SCLC) and other solid tumors that have a specific marker called DLL3. Researchers want to see how safe and tolerable this treatment is, how it moves through the body, and if it shows any early signs of shrinking tumors. You might be able to join if you are at least 18 years old and have advanced SCLC or large cell neuroendocrine carcinoma (LCNEC) of the lung, especially if your cancer has progressed after other treatments. The study is also looking at an imaging agent, [203Pb]Pb-MP0712, to help understand the treatment better. The study is currently recruiting about 138 participants.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves a dose escalation part to find the right dose, followed by a dose expansion part to further evaluate the treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 5 years after your last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07278479

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Molecular Partners AG
~138 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:[212Pb]Pb-MP0712[203Pb]Pb-MP0712

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279
Measured over until 5 years after last dose
+3 more outcomes measured

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

Explore related trials

Large Cell Neuroendocrine CarcinomaLung Small Cell CarcinomaNeuroendocrine CarcinomaSolid NeoplasmDLL3 Gene

Where it's being run

5 sites across 5 states
Georgia1
Maryland1
Nebraska1
New Jersey1
Ohio1

Who to contact

Medical Director MPAG
[email protected]
+41 44 755 77 00
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279until 5 years after last dose

    Type, frequency and severity of adverse events (AEs), and serious adverse events (SAEs), Adverse events of special interest (AESI) and Dose Limiting Toxicities (DLT) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

  • To assess dose modifications of [212Pb]Pb-DOTAM-MAM279until 5 years after last dose

    Frequency and duration of dose changes

  • To estimate the maximum tolerated dose (MTD) and/or to define the recommended phase 2 dose (RP2D) for SCLC/LCNEC of the lung and epNECsPhase 1, from start of treatment to end of first cycle (day 1 - 28)

    Incidence of dose limiting toxicities

  • To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion partPhase 2a only; 12 months

    Objective Response Rate (ORR) in the expansion phase ORR is defined as the percentage of patients with partial response (PR) or complete response (CR) as per RECIST v1.1