138 Participants Needed

[212Pb]Pb-MP0712 for Small Cell Lung Cancer

MD
Overseen ByMedical Director MPAG
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Molecular Partners AG
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called [212Pb]Pb-MP0712 for individuals with small cell lung cancer and other advanced tumors that display a marker called DLL3. The primary goal is to assess the treatment's safety and effectiveness. Participants may qualify if they have small cell lung cancer or certain other cancers that have recurred after treatment and possess a DLL3 marker. The trial also includes imaging procedures to guide the treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that [212Pb]Pb-MP0712 is being tested for safety in treating small cell lung cancer. Earlier studies on a similar treatment, [212Pb]Pb-DOTAM-MAM279, focused on safety and patient tolerance. These studies examined the frequency and severity of safety issues after treatment. This research helps identify possible side effects and assess patient tolerance. Since this trial is in the early stages (Phase 1/2), the treatment is still being tested for human safety. Some side effects may occur, and the study aims to identify and manage them.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about [212Pb]Pb-MP0712 for small cell lung cancer because it uses a novel mechanism involving targeted alpha therapy. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, this treatment delivers radiation precisely to the cancer cells. The use of the active ingredient [212Pb] (Lead-212) allows for more focused treatment, potentially reducing side effects. This precision could lead to more effective outcomes and a better quality of life for patients.

What evidence suggests that this trial's treatments could be effective for Small Cell Lung Cancer?

Research has shown that [212Pb]Pb-MP0712, the investigational treatment in this trial, may effectively treat small cell lung cancer. Studies indicate that this treatment can reach tumors well, even when the DLL3 protein is present at low levels. DLL3, a target found in some cancer cells, helps the treatment focus specifically on the cancer. Previous data from similar treatments, such as 212Pb-DOTAMTATE, showed that 54.3% of patients experienced tumor shrinkage. This suggests that [212Pb]Pb-MP0712 could also help shrink tumors in small cell lung cancer and similar conditions.12346

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of advanced lung cancer or neuroendocrine carcinomas that express DLL3, and have progressed after at least two prior treatments including platinum-based therapy and immunotherapy. Participants must have measurable disease progression, adequate organ function, and no previous adverse reactions to similar radioactive therapies.

Inclusion Criteria

I am 18 years old or older.
My lung cancer is confirmed by lab tests to be small cell or large cell.
I have previously received treatment targeting DLL3.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of [212Pb]Pb-DOTAM-MAM279 to determine the maximum tolerated dose

4 weeks
Weekly visits for dose administration and monitoring

Dose Expansion

Participants receive the recommended phase 2 dose to further evaluate safety and preliminary anti-tumor activity

12 months
Monthly visits for treatment and evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Annual visits for long-term monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • [212Pb]Pb-MP0712

Trial Overview

[212Pb]Pb-MP0712 is being tested for safety, tolerability, dosage measurement, and initial effectiveness in treating DLL3 positive tumors. This includes patients with small cell lung cancer (SCLC) who've had multiple prior treatments but still show tumor growth.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: [203Pb]Pb-DOTAM-MAM279/[212Pb]Pb-DOTAM-MAM279Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Molecular Partners AG

Lead Sponsor

Trials
14
Recruited
4,000+

Orano Med LLC

Industry Sponsor

Trials
4
Recruited
150+

Citations

Study of [212Pb]Pb-DOTAM-MAM279 in Patients With Small ...

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [212Pb]Pb-DOTAM-MAM279, in patients ...

212Pb-DOTAMTATE Shows Impressive Antitumor Activity ...

Previously reported data for cohort 1 showed that 212Pb-DOTAMTATE achieved an ORR of 54.3% and a manageable safety profile in PRRT-naïve ...

NCT07278479 | Study of [212Pb]Pb-DOTAM-MAM279 in ...

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [212Pb]Pb-DOTAM-MAM279, in patients ...

Study of [212Pb]Pb-DOTAM-MAM279 in Patients With ...

To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion part, Objective Response Rate (ORR) in the expansion phase$#\r#$ ...

Molecular Partners Presents New Data for DLL3 Targeting ...

The data suggests that MP0712 can achieve high tumor uptake in spite of very low DLL3 expression levels, leveraging internalization and ...

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