What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy regimens such as etoposide combined with either cisplatin or carboplatin, and immune checkpoint inhibitors like atezolizumab. Known side effects of these treatments can include nausea, vomiting, hair loss, fatigue, increased risk of infection, and low blood cell counts. Immune checkpoint inhibitors may also cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. For bispecific antibodies like PT217 targeting DLL3 and CD47, potential side effects could include infusion reactions, cytopenias, and immune-related adverse events, although specific data on PT217's side effects are not yet available.

What prior FDA approvals exist?

FDA-approved treatments for Small Cell Lung Cancer (SCLC) primarily include chemotherapy regimens such as etoposide with either cisplatin or carboplatin, and more recently, immune checkpoint inhibitors like atezolizumab and nivolumab. These treatments focus on enhancing the immune response against cancer cells. While there are no FDA-approved bispecific antibodies targeting DLL3 and CD47 specifically for SCLC, the approval of immune checkpoint inhibitors indicates a growing interest in immunotherapy approaches, which aligns with the mechanism of action of PT217 being studied in the trial.

What other types of research exist?

Promising novel alternatives to PT217 for Small Cell Lung Cancer patients include: 1) MG1122-B, a bispecific antibody targeting mesothelin and CD3ε, which has shown efficacy in mesothelin-positive tumors. 2) Pembrolizumab, an immune checkpoint inhibitor, which has demonstrated improved overall survival when combined with chemotherapy in non-small cell lung cancer and may have potential in SCLC. 3) Avelumab, a PD-L1 inhibitor, which has shown durable responses in mesothelioma and could be considered for SCLC. These alternatives represent different mechanisms of action and have shown promise in clinical settings.

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Monoclonal Antibodies

PT217 for Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Phanes Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to antibody therapies such as infusion-related reactions, immune system complications leading to inflammation in various organs, fatigue, allergic responses to ingredients in PT217.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine recommended Phase 2 dose (RP2D) of PT217.

To determine the dose-limiting toxicity (DLT) of PT217.

To determine the maximum tolerated dose (MTD) of PT217 if reached.

Secondary study objectives

Preliminary efficacy of PT217 as assessed by Progression Free Survival by iRECIST and RECIST 1.1.

Preliminary efficacy of PT217 as assessed by the 6-month Overall Survival by iRECIST and RECIST 1.1.

Preliminary efficacy of PT217 as assessed by the Disease Control Rate by iRECIST and RECIST 1.1.

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment1 Intervention

There will be two Dose Expansion Cohorts: Both cohorts will include SCLC, LCNEC and EP-NEC patients. Half of the enrolled patients should be SCLC and LCNEC. * Cohort 1 will use RDE1 a dose level that has been identified as an appropriate dose based on safety and PK data from Part A. * Cohort 2 will study a different dose level from RDE1, termed RDE2. This dose may be higher or lower than RDE1 but will not exceed the MTD.

Group II: Dose EscalationExperimental Treatment1 Intervention

A standard 3+3 dose escalation design will be employed. The starting dose of PT217 to be evaluated in the dose escalation study is 0.2 mg/kg weekly (QW). Additional provisional dose levels include: 0.6 mg/kg QW, 2 mg/kg QW, 6 mg/kg QW and 12 mg/kg QW.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy, often using etoposide combined with platinum-based drugs like cisplatin or carboplatin, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immunotherapy, such as anti-PD-1 or anti-PD-L1 antibodies, enhances the immune system's ability to recognize and destroy cancer cells. Targeted therapies, like the bispecific antibody PT217, target specific proteins expressed on cancer cells. PT217 targets DLL3, which is commonly expressed on SCLC cells, and CD47, which helps cancer cells evade the immune system. By targeting these proteins, PT217 aims to directly kill cancer cells and enhance immune-mediated destruction. These mechanisms are crucial for SCLC patients as they address the aggressive nature of the disease and its tendency to develop resistance to standard treatments.