A Phase 1/2 interventional study of [212Pb]Pb-MP0712 and [203Pb]Pb-MP0712 in Large Cell Neuroendocrine Carcinoma, Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC) and Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), sponsored by Molecular Partners AG. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Molecular Partners AG · Phase 1/2, Interventional, and Treatment
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.
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.
Key Inclusion Criteria:
Histologically or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Patients will receive \[203Pb\]Pb-DOTAM-MAM279 for Imaging/Dosimetry followed by \[212Pb\]Pb-DOTAM-MAM279 for treatment
Drug: [212Pb]Pb-MP0712 · Other: [203Pb]Pb-MP0712
Radioligand Therapy
Also known as: [212Pb]Pb-DOTAM-MAM279
Radioligand Imaging Agent
Also known as: [203Pb]Pb-DOTAM-MAM279
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)
Time frame: until 5 years after last dose
To assess dose modifications of [212Pb]Pb-DOTAM-MAM279
Frequency and duration of dose changes
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
Incidence of dose limiting toxicities
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
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
Time frame: Phase 2a only; 12 months
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
Time frame: 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
Blood and serum samples will be drawn to determine AUC of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: 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
Blood and serum samples will be drawn to determine half-live(s) (t½) of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
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
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
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
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
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
Time frame: Phase 1; up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration
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
Time frame: up to 10 days following [203Pb]Pb-DOTAM-MAM279 administration
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
Time frame: Phase 2a only; 12 months
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
Time frame: Phase 2a only; 12 months
To evaluate DCR
Disease control rate (DCR) defined as the percentage of patients who have achieved CR, PR, or stable disease (SD)
Time frame: Phase 2a only; 12 months
To evaluate OS
Overall survival (OS) defined as the time from C1D1 to death from any cause
Time frame: Phase 2a only; approx. 5 years
Plan to share: Undecided
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Molecular Partners AG