[212Pb]Pb-MP0712 for Small Cell Lung Cancer and Other Tumors
Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Large 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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
138 (estimated)
Sponsor
Molecular Partners AG · Industry
Who this trial is looking for
This trial is looking for adults with small cell lung cancer or other specific tumors that produce a protein called DLL3. Participants will receive a new treatment called [212Pb]Pb-MP0712 to see how well it works and what side effects it may have.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with small cell lung cancer or a DLL3-expressing tumor.
I have had disease progression or recurrence after previous treatments.
I have measurable disease.
I have enough healthy blood cells and organ function.
I do not have significant heart disease.
I have no unresolved serious side effects from past treatments.
I am stable if I have known brain metastases.
You may not be able to join if
I have an uncontrolled illness.
I have had serious side effects from prior cancer treatments that are not resolved.
I have active significant cardiac disease.
I have evidence of lung disease or inflammation.
I have a history of other cancer in the past 2 years, with some exceptions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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…
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 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.
Key Exclusion Criteria:
* 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.
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