PT217 for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Peluntamig (PT217) for small cell lung cancer and similar conditions. The goal is to assess the safety and effectiveness of PT217, both alone and in combination with other treatments like chemotherapy. The trial is divided into parts to explore different doses and combinations. Suitable participants have advanced or metastatic small cell lung cancer, or similar cancers, that have not responded well to standard treatments. Participants must have the main type of cancer, be able to provide a tumor sample, and meet certain health criteria. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before starting the study. Specifically, you must not have taken systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives, corticosteroids or other immunosuppressive medications within 14 days, or therapeutic antibiotics within 2 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Peluntamig (PT217) is generally safe. In animal studies, PT217 was well-tolerated and did not cause serious side effects. When used alone, it demonstrated strong effects against tumors, which is promising for treating small cell lung cancer.
Early reports suggest that PT217, when combined with chemotherapy, is being tested safely, as patients have begun treatment in trials without major safety issues. Combining it with immune checkpoint inhibitors like atezolizumab also appears promising. These inhibitors help the immune system fight cancer more effectively. Previous studies have shown that these combinations can work well and are usually safe.
Overall, while PT217 remains in early testing, current evidence suggests it is safe enough for further testing. However, ongoing studies will continue to monitor its safety in humans.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for small cell lung cancer, which often include chemotherapy and immunotherapy drugs, PT217 introduces a novel approach by combining with both chemotherapy and immunotherapy in separate cohorts. PT217, also known as Peluntamig, is an exciting development because it combines the potential benefits of these traditional treatments while aiming to enhance their effectiveness. Researchers are particularly interested in its ability to work synergistically with atezolizumab, an existing immunotherapy, which might improve patient outcomes by targeting cancer cells more effectively. This combination strategy could potentially lead to more personalized and effective treatment plans for patients.
What evidence suggests that PT217 might be an effective treatment for small cell lung cancer?
Research has shown that Peluntamig (PT217) is being tested as a potential treatment for small cell lung cancer (SCLC). This treatment targets a protein called DLL3, often found in large amounts on cancer cells. Early results suggest that PT217 can help the immune system attack these cancer cells. Specifically, studies reported that patients using PT217 had a median progression-free survival of 4.3 months and a median overall survival of 15.2 months.
In this trial, researchers are studying PT217 in different treatment arms. In Part C, PT217 is combined with chemotherapy, which may enhance the treatment's effectiveness. Additionally, in Part D, PT217 is combined with atezolizumab, a drug that helps the immune system fight cancer, potentially providing extra benefits.14567Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic cancers like SCLC, LCNEC, NEPC, and GEP-NET that have worsened after standard treatments. Participants must have a tumor predominantly made up of neuroendocrine cells and be able to provide a tissue sample. They should not have serious heart conditions, uncontrolled infections or other medical issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
A standard 3+3 dose escalation design to determine the recommended dose for expansion
Dose Expansion
Participants receive Peluntamig (PT217) at the recommended dose to further evaluate safety and efficacy
Chemotherapy Combination Therapy
Peluntamig (PT217) is combined with chemotherapy to assess safety and efficacy
ICI Combination Therapy
Peluntamig (PT217) is combined with atezolizumab, with or without chemotherapy, to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PT217
Trial Overview
PT217 is being tested in this Phase 1 trial. It's an experimental antibody targeting DLL3 and CD47 proteins on cancer cells. The study aims to assess its safety, tolerability, how the body processes it (pharmacokinetics), and initial effectiveness against certain refractory cancers.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.
Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy.
Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.
A standard 3+3 dose escalation design will be employed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phanes Therapeutics
Lead Sponsor
Hoffmann-La Roche
Industry Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
Phanes Therapeutics announces first patient dosed in ...
The study is being conducted in a cohort of patients with extensive-stage small cell lung cancer (ES-SCLC), large cell neuroendocrine carcinoma ...
An open-label, multicenter, phase 1/2 study of peluntamig ...
Peluntamig (PT217) is an IgG1 based anti-DLL3/anti-CD47 bispecific antibody that activates both innate and adaptive immunity to target cells that express DLL3 ...
A Study of Peluntamig (PT217) in Patients With ...
The multi-center Phase I clinical trial of PT217 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 ...
NCT05652686 | A Study of Peluntamig (PT217) in Patients ...
This is a first-in-human, Phase 1/2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, ...
Advances in immuno-based and targeted therapies in ...
Immune checkpoint inhibitors (ICIs), represented by atezolizumab and durvalumab, have shown encouraging therapeutic effects in the combination ...
An open-label, multicenter, phase 1/2 study of peluntamig ...
Peluntamig (PT217) is an IgG1 based anti-DLL3/anti-CD47 bispecific antibody that activates both innate and adaptive immunity to target cells that express DLL3 ...
1811TiP SKYBRIDGE study: An open-label, multicenter ...
Cohorts include PT217 monotherapy and combinations with Atezolizumab in frontline and relapsed SCLC, LCNEC and EP-NEC. Two frontline cohorts, one in SCLC ...
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