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New treatment option for Large Cell Neuroendocrine Carcinoma
Official title Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
ClinicalTrials.gov ID: NCT07278479
What this study is testing
What is [212Pb]Pb-MP0712?
[212Pb]Pb-MP0712 is an investigational medicine, being studied as a potential treatment for large cell neuroendocrine carcinoma.
Also referred to as [212Pb]Pb-DOTAM-MAM279.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Gastroenteropancreatic NECs (GEPNEC), or
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Glen Burnie, Maryland, United States
- Omaha, Nebraska, United States
- Princeton, New Jersey, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Glen Burnie, Maryland, United States; Omaha, Nebraska, United States; Princeton, New Jersey, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.