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

ConditionsLarge Cell Neuroendocrine CarcinomaLarge 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 BladderOther DLL3 Expressing epNEC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMolecular Partners AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Gastroenteropancreatic NECs (GEPNEC), or

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • [212Pb]Pb-MP0712

    Drug

    Radioligand Therapy

  • [203Pb]Pb-MP0712

    Other intervention

    Radioligand Imaging Agent

Treatment groups

138 Participants
are divided into 1 treatment group
Group A: [203Pb]Pb-DOTAM-MAM279/[212Pb]Pb-DOTAM-MAM279Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Time frame
until 5 years after last dose
2

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

Frequency and duration of dose changes

Time frame
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

Time frame
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

Time frame
Phase 2a only; 12 months

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Molecular Partners AG

Lead sponsor

Orano Med LLC

Collaborator

Source ClinicalTrials.gov
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