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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 up to 5 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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part D: ICI Combination TherapyExperimental Treatment3 Interventions
In part D, 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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
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.
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Who is running the clinical trial?
Hoffmann-La RocheIndustry Sponsor
2,459 Previous Clinical Trials
1,098,022 Total Patients Enrolled
Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been treated for an autoimmune disease in the last year.I have not had treatments targeting T-cell, NK cell, DLL3, CD47, or anti-SIRPα.My cancer is advanced, cannot be surgically removed, and has not responded to or cannot be treated with standard care.I have another cancer that is getting worse or was treated in the last 2 years.I haven't taken steroids or immunosuppressants in the last 14 days.I have been diagnosed with HIV.I have not had major surgery in the last 4 weeks.My cancer has spread to my brain or central nervous system and is not treated or is getting worse.I have severe nerve damage.I have had lung inflammation that needed steroids or have a lung condition.I frequently need procedures to remove excess fluid from my chest or abdomen.I am currently on blood thinners like warfarin.I am 18 or older and can follow study rules.I do not have any severe illnesses besides my current condition.My organs are functioning well, as confirmed by recent tests.I have heart problems or significant diseases.My side effects from previous cancer treatments are mild or gone.I am fully active or can carry out light work.I can provide a specific type of tumor tissue sample for testing.I haven't had chemotherapy, targeted therapy, or immunotherapy in the last 4 weeks.I haven't taken any experimental drugs within the last 4 weeks or 5 half-lives before starting the study drug.My tumor is mostly made up of neuroendocrine/small tumor cells.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Escalation
- Group 2: Part B: Dose Expansion
- Group 3: Part C: Chemotherapy Combination Therapy
- Group 4: Part D: ICI Combination Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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