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 Carcinoma Large 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 Bladder Other 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

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

Treatments tested in this trial

[212Pb]Pb-MP0712
[203Pb]Pb-MP0712

Treatment groups

138 Participants

are divided into 1 treatment group

Sponsors and collaborators

Molecular Partners AG

Lead sponsor

Orano Med LLC

Collaborator

Source ClinicalTrials.gov