Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
About this study
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.
- Condition
- Large 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
- Tested
- [212Pb]Pb-MP0712, [203Pb]Pb-MP0712
- Sponsor
- Molecular Partners AG
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 19
- Minimum age: 18 years
- Study condition: Large 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
- 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
- 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.
Exclusion 6
- 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.
Where
6 sites, 6 recruiting
Emory University Hospital
Atlanta, Georgia, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
United Theranostics
Glen Burnie, Maryland, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
United Theranostics
Princeton, New Jersey, United States
Moffitt Cancer Center
Tampa, Florida, United States
Contact
-
Medical Director MPAG
+41 44 755 77 00 info@molecularpartners.com
Potential match only. Final eligibility is determined by the study team.