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Pb-MP0712

Phase 1

Large Cell Neuroendocrine Carcinoma | Small molecule | Oncology |Molecular Partners AG|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment138
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07278479Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid TumorsPHASE1 RECRUITING 138 — — May 18, 2026Sep 1, 2032May 22, 20265 United States
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Study Endpoints
Primary Endpoints
To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279
until 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-MAM279
until 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 epNECs
Phase 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 part
Phase 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

Secondary Endpoints
To assess maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the area under the curve (AUC) from time 0 to the time of the last quantifiable concentration of [203Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[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
Interventions
NameTypeDescription
[212Pb]Pb-MP0712DRUGRadioligand Therapy
[203Pb]Pb-MP0712OTHERRadioligand Imaging Agent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 t...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07278479primaryCompletionDate: changed
LOWMay 24, 2026NCT07278479studyFirstPostDate: changed