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Monoclonal Antibodies
PT217 for Small Cell Lung Cancer
Phase 1
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
Study Summary
This trial will evaluate a new treatment for advanced or refractory cancer. It's designed to test safety, effectiveness and how medicine is processed in the body.
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.Check my eligibility
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.See study design
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
+1 moreSecondary outcome measures
Preliminary efficacy of PT217
To evaluate the pharmacokinetics of PT217
Other outcome measures
Disease Control Rate (DCR = PR+CR+SD)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
There will be two Dose Expansion Cohorts:
Cohort 1: RP2D, with a focus on SCLC patients. Cohort 2: RP2D minus 1 dose level, with a focus on all neuroendocrine cancer patients (limit of n=5 that are not SCLC).
Group II: Dose EscalationExperimental Treatment1 Intervention
An accelerated titration design will be employed, and 1 patient will be enrolled initially at each of the lower dose levels: 0.2 mg/kg, 0.6 mg/kg and 2 mg/kg. The starting dose to be evaluated in the dose escalation study is 0.2 mg/kg weekly (QW). Additional provisional dose levels include: 6 mg/kg QW, 12 mg/kg QW.
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Who is running the clinical trial?
Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
154 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: Dose Expansion
- Group 2: Dose Escalation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the Food and Drug Administration authorize dosage increments for this medication?
"Due to the limited data available on Dose Escalation, our team at Power has rated it's safety a 1 on a scale from 1 to 3. This is because Phase 1 trials typically provide minimal evidence of effectiveness and safeguard."
Answered by AI
To what extent has recruitment for this clinical trial been completed?
"Affirmative. According to the information presented on clinicaltrials.gov, this trial commenced recruitment on June 1st 2023 and was updated recently on June 14th 2023. The research necessitates 58 volunteers from a single medical centre."
Answered by AI
Are more test subjects being recruited for this experiment?
"According to clinicaltrials.gov, this investigation is still open for enrollment as of June 14th 2023. Recruitment opened on the 1st day of June in the same year."
Answered by AI
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