203 Participants Needed

PT217 for Small Cell Lung Cancer

Recruiting at 11 trial locations
PT
Overseen ByPhanes Therapeutics
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 is testing a new antibody treatment called PT217 for patients with certain neuroendocrine cancers who haven't responded to usual treatments. PT217 helps the immune system target and destroy cancer cells by attaching to specific proteins on them.

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.

Are 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

My cancer is advanced, cannot be surgically removed, and has not responded to or cannot be treated with standard care.
Measurable disease as defined by RECIST v1.1 criteria for solid tumors
My organs are functioning well, as confirmed by recent tests.
See 7 more

Exclusion Criteria

I have not had wide field radiotherapy in the last 2 weeks.
I have not received a live-virus vaccine in the last 30 days.
I am not pregnant or breastfeeding.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

A standard 3+3 dose escalation design to determine the recommended dose for expansion

8-12 weeks

Dose Expansion

Participants receive Peluntamig (PT217) at the recommended dose to further evaluate safety and efficacy

12-16 weeks

Chemotherapy Combination Therapy

Peluntamig (PT217) is combined with chemotherapy to assess safety and efficacy

12-16 weeks

ICI Combination Therapy

Peluntamig (PT217) is combined with atezolizumab, with or without chemotherapy, to assess safety and efficacy

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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?
4Treatment groups
Experimental Treatment
Group I: Part D: ICI Combination TherapyExperimental Treatment3 Interventions
Group II: Part C: Chemotherapy Combination TherapyExperimental Treatment3 Interventions
Group III: Part B: Dose ExpansionExperimental Treatment1 Intervention
Group IV: Part A: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Phanes Therapeutics

Lead Sponsor

Trials
3
Recruited
380+

Hoffmann-La Roche

Industry Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

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