RightFit
RecruitingPhase 1 / Phase 2

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

A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [212Pb]Pb-MP0712 in adults with small cell lung cancer and certain other advanced cancers with a protein called DLL3. It checks safety, side effects, how much radiation reaches the body’s tissues, and early signs that the treatment works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old.
  • Your cancer must be confirmed by a tissue or cell test. Eligible types include small cell lung cancer, large-cell neuroendocrine lung cancer, and certain neuroendocrine cancers outside the lungs.
  • For small cell lung cancer, the cancer must have grown or returned after at least two prior treatment courses involving platinum-based drugs and immune therapy, or standard second treatment must not be suitable or tolerated.
  • For large-cell neuroendocrine lung cancer or eligible neuroendocrine cancers outside the lungs, the cancer must have grown or returned after at least one treatment that acts throughout the body.
  • Eligible cancers outside the lungs include those in the digestive tract, pancreas, cervix, or bladder. Other sites need a prior tissue test showing DLL3. Past DLL3-targeted treatment is allowed.
  • A special scan must show DLL3 for cancers outside the lungs in Parts 1 and 2, and for eligible lung cancers in Part 2.
  • Scans must show that the cancer grew or returned during or after the last treatment. At least one tumor must be measurable.
  • Blood counts and liver and kidney function must meet study limits. Cancer that has spread to the brain or spinal cord is allowed if it is stable.

Who can't join

  • You have another illness that is not under control.
  • Significant side effects from past cancer treatment have not improved to mild or less. Some hair loss or stable, moderate nerve damage affecting sensation is allowed.
  • You have active, significant heart disease.
  • You have lung tissue disease called interstitial lung disease, or active lung inflammation not caused by infection.
  • You have had another cancer within the past 2 years, though some exceptions apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (6)

FL

GA

MD

NE

NJ

OH