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Large Cell Neuroendocrine CarcinomaPhase 1/2NCT07278479

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

A Phase 1/2 study testing [212Pb]Pb-MP0712 and [203Pb]Pb-MP0712 in people with Large Cell Neuroendocrine Carcinoma and Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC), run by Molecular Partners AG at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[212Pb]Pb-MP0712 and [203Pb]Pb-MP0712
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
8 sitesUnited States
Study dates
18 May 2026to Sep 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Medical Director MPAG contact

+41 44 755 77 00

info@molecularpartners.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Ryan Hanula, 404-778-5141, rhanula@emory.edu

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Dr A.Dowlati, 216-368-1122, afshin.dowlati@uhhospitals.org

    Recruiting

  • United Theranostics

    Glen Burnie, Maryland, 21061

    Amanda Huggins, 667-HOPENOW, clinicaltrial@unithera.com

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Research Director, 402-955-2691, clinicaltrials@nebraskacancer.com

    Recruiting

  • United Theranostics

    Princeton, New Jersey, 08540

    Amanda Huggins, 667-HOPENOW, clinicaltrial@unithera.com

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This is a phase I/IIa, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of [212Pb]Pb-MP0712 in patients with SCLC and other advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) [212Pb]Pb-MP0712 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of [212Pb]Pb-MP0712. The study will enable evaluation of the safety, dosimetry, PK, and imaging properties of [203Pb]Pb-MP0712.

Being tested
[212Pb]Pb-MP0712, [203Pb]Pb-MP0712
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
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [212Pb]Pb-MP0712Drug

    Also called [212Pb]Pb-DOTAM-MAM279

    Radioligand Therapy

  • [203Pb]Pb-MP0712Other

    Also called [203Pb]Pb-DOTAM-MAM279

    Radioligand Imaging Agent

Study groups in NCT07278479
Study groupRoleWhat they receive
[203Pb]Pb-DOTAM-MAM279/[212Pb]Pb-DOTAM-MAM279ExperimentalPatients will receive [203Pb]Pb-DOTAM-MAM279 for Imaging/Dosimetry followed by [212Pb]Pb-DOTAM-MAM279 for treatment
Receives: Drug: [212Pb]Pb-MP0712; Other: [203Pb]Pb-MP0712

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279

    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)

    Measured: until 5 years after last dose

  2. To assess dose modifications of [212Pb]Pb-DOTAM-MAM279

    Frequency and duration of dose changes

    Measured: until 5 years after last dose

  3. 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

    Incidence of dose limiting toxicities

    Measured: Phase 1, from start of treatment to end of first cycle (day 1 - 28)

  4. To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion part

    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

    Measured: Phase 2a only; 12 months

Secondary outcomes (11)

  1. To assess maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Blood and serum samples will be drawn to determine maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Measured: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

  2. To assess the area under the curve (AUC) from time 0 to the time of the last quantifiable concentration of [203Pb]Pb-DOTAM-MAM279

    Blood and serum samples will be drawn to determine AUC of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Measured: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

  3. To assess half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Blood and serum samples will be drawn to determine half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Measured: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

  4. To assess the clearance (CL) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Blood and serum samples will be drawn to determine clearance (CL) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Measured: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

  5. To assess the volume of distribution (Vd) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Blood and serum samples will be drawn to determine the volume of distribution (Vd) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279

    Measured: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]

  6. To quantitatively predict radiation absorbed doses for therapeutic [212Pb]Pb-DOTAM-MAM279 from [203Pb]Pb-DOTAM-MAM279

    Estimation of [212Pb]Pb-DOTAM-MAM279 absorbed dose for healthy organs and tumor lesions based on dosimetry analysis of [203Pb]Pb-DOTAM-MAM279

    Measured: Phase 1; up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration

  7. To assess incidence and severity of safety events following administration of [203Pb]Pb-DOTAM-MAM279

    Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: up to 10 days following [203Pb]Pb-DOTAM-MAM279 administration

  8. To evaluate PFS

    Progression-Free Survival (PFS) determined as the time from C1D1 to the date of progression, defined as the first documented progression as per RECIST v1.1 or death for any cause

    Measured: Phase 2a only; 12 months

  9. To evaluate DoR

    Duration of response (DoR) in patients with a CR or PR from date of first date of response to the date of RECIST 1.1 progression or death

    Measured: Phase 2a only; 12 months

  10. To evaluate DCR

    Disease control rate (DCR) defined as the percentage of patients who have achieved CR, PR, or stable disease (SD)

    Measured: Phase 2a only; 12 months

  11. To evaluate OS

    Overall survival (OS) defined as the time from C1D1 to death from any cause

    Measured: Phase 2a only; approx. 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start18 May 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a phase 1/2a, multicenter, open-label study evaluating the safety, tolerability, and preliminary efficacy of \[212Pb\]Pb-DOTAM-MAM279 in patients with: * SCLC or LC NECs of the lung * epNECs The study is divided into two parts: * Part 1 (Phase 1): Dose escalation * Part 2 (Phase 2a): Dose expansion
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278479
Sponsor's protocol ID
MP0712-CP101
Status last verified
May 2026
First submitted
10 Nov 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing [212Pb]Pb-MP0712 and [203Pb]Pb-MP0712 in people with Large Cell Neuroendocrine Carcinoma and Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC), run by Molecular Partners AG at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Director MPAG (+41 44 755 77 00, info@molecularpartners.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07278479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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