PT217 for Small Cell Lung Cancer

Recruiting at 11 trial locations

Overseen By Phanes Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Phanes Therapeutics

Must not be taking: Immunostimulatory agents, Corticosteroids

Disqualifiers: Pregnancy, Autoimmune disease, Untreated brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

203 Participants Needed

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.

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.

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?

Group I: Part D: ICI Combination Therapy Experimental Treatment 3 Interventions

In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy.

Group II: Part C: Chemotherapy Combination Therapy Experimental Treatment 3 Interventions

Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy.

Group III: Part B: Dose Expansion Experimental Treatment 1 Intervention

Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D.

Group IV: Part A: Dose Escalation Experimental Treatment 1 Intervention

A standard 3+3 dose escalation design will be employed.

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

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