Recruiting

Phase 1

Phase 2

\[212Pb\]Pb-MP0712Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors

Sponsor:

Molecular Partners AG

Code:

NCT07278479

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)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[212Pb]Pb-MP0712

[203Pb]Pb-MP0712

Study Details

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.

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)

Study ID

NCT07278479

Start date

May 18, 2026

Status verified date

May, 2026

Completion date

Sep, 2032

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

Key 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

138 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [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

Interventions

[212Pb]Pb-MP0712

Radioligand Therapy

[203Pb]Pb-MP0712

Radioligand Imaging Agent

Primary outcome measure

To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279 [ Time Frame: until 5 years after last dose ]
To assess dose modifications of [212Pb]Pb-DOTAM-MAM279 [ Time Frame: until 5 years after last dose ]
To estimate the maximum tolerated dose (MTD) and/or to define the recommended phase 2 dose (RP2D) for SCLC/LCNEC of the lung and epNECs [ Time Frame: Phase 1, from start of treatment to end of first cycle (day 1 - 28) ]
To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion part [ Time Frame: Phase 2a only; 12 months ]

Central Contacts and Locations

Central contacts

Medical Director MPAG

+41 44 755 77 00 info@molecularpartners.com

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Ryan Hanula

404-778-5141 rhanula@emory.edu

United Theranostics

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Amanda Huggins

667-HOPENOW clinicaltrial@unithera.com

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Research Director

402-955-2691 clinicaltrials@nebraskacancer.com

United Theranostics

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Amanda Huggins

667-HOPENOW clinicaltrial@unithera.com

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Dr A.Dowlati

216-368-1122 afshin.dowlati@uhhospitals.org

More Information

Sponsor

Molecular Partners AG

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

DARPin
Alpha Emitter
Pb203
Pb212
DLL3
Radioligand therapy (RLT)
SCLC
Neuroendocrine cancer
[203Pb]Pb-DOTAM-MAM279
[212Pb]Pb-DOTAM-MAM279
EP-NEC
Lead 212
Lead 203
203Pb
212Pb

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Molecular Partners AG on 2026-05-22.