Only 126 spots left

~126 spots leftby Dec 2027

PT217 for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Phanes Therapeutics

Must not be taking: Immunostimulatory agents, Corticosteroids

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

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

Research Team

Eligibility Criteria

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

I am 18 or older and can follow study rules.

See 8 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

Trial Timeline

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

Treatment Details

Interventions

PT217 (Monoclonal Antibodies)

Trial OverviewPT217 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.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Part D: ICI Combination TherapyExperimental Treatment3 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 TherapyExperimental Treatment3 Interventions

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

Group III: Part B: Dose ExpansionExperimental Treatment1 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 EscalationExperimental Treatment1 Intervention

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