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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1
Adequate organ function confirmed at screening and within 7 days of initiating treatment, as evidenced by:
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 2 years.
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new drug, PT199, to see if it is safe and effective for treating patients with solid tumors that have not responded to other treatments.
Eligible Conditions
- Pancreatic Adenocarcinoma
- Lung Cancer
- Pancreatic Cancer
- Cancer
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are in good enough shape to perform daily activities without any problems, or with only a little trouble.
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Your organs must be working well when tested before starting the treatment.
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You have at least one detectable tumor that can be measured according to specific guidelines.
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You have advanced or metastatic solid tumors that have been treated with all standard therapies available, or there are no other treatment options for you.
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You need to provide a sample of tumor tissue that has been preserved in a certain way, so it can be tested for specific markers like CD73 and PD-L1.
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Women who can have children need to have a negative pregnancy test before starting the study treatment.
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Any side effects from previous cancer treatments should be mostly gone or very mild.
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
Maximum Tolerated Dose (MTD), if reached.
RP2D of PT199 as a single agent and/or in combination with a PD-1 inhibitor.
Secondary outcome measures
PK Parameters.
Preliminary Efficacy (assessed by the response rate by iRECIST and RECIST 1.1).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part C Combination Therapy Dose ExpansionExperimental Treatment2 Interventions
Approximately 8 additional patients will be treated in a dose expansion cohort at the MTD/DRDE
Group II: Part B Combination Therapy Dose EscalationExperimental Treatment2 Interventions
A standard 3+3 dose escalation design will be employed, and 3 patients will be enrolled initially at each dose level. The starting dose of PT199 to be evaluated in the dose escalation study is 20 mg/kg weekly (QW). The dose level of PD-1 inhibitor in all provisional dose levels will be 200 mg once every 3 weeks (Q3W).
Group III: Part A Monotherapy Dose EscalationExperimental Treatment1 Intervention
A standard 3+3 dose escalation design will be employed, and 3 patients will be enrolled initially at each dose level. The starting dose of PT199 to be evaluated in the dose escalation study is 10 mg/kg weekly (QW). Additional provisional dose levels include: 20 mg/kg QW, and 30 mg/kg QW.
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Who is running the clinical trial?
Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
116 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an autoimmune disease that needed strong medication in the last year.You are allergic to immune checkpoint inhibitor therapy or any of its inactive ingredients.You have not received T-cell, NK cell, or CD73 inhibitor therapy before (But, you have received Checkpoint inhibitor anti PD-1 and anti PD-L1 therapies before).You are in good enough shape to perform daily activities without any problems, or with only a little trouble.You have a history of lung inflammation that needed steroids, or you currently have lung inflammation, or you have had a specific type of lung disease in the past.You have brain or central nervous system metastases that have not been treated, or have progressed despite treatment. If you have been treated for brain metastases and have been stable for 28 days without needing corticosteroids, you can participate.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin or cervical cancers that have been treated before.You have other serious medical conditions that are not well-controlled and could pose risks for your safety or affect your ability to follow the study's plan.You are currently taking a specific type of blood thinner called warfarin sodium or similar medications.You have been diagnosed with HIV, but if your condition is well controlled, you may still be able to participate with approval from the study team.You have at least one detectable tumor that can be measured according to specific guidelines.You have advanced or metastatic solid tumors that have been treated with all standard therapies available, or there are no other treatment options for you.You need to provide a sample of tumor tissue that has been preserved in a certain way, so it can be tested for specific markers like CD73 and PD-L1.Women who can have children need to have a negative pregnancy test before starting the study treatment.Any side effects from previous cancer treatments should be mostly gone or very mild.You have a current, uncontrolled Hepatitis B or Hepatitis C infection. If you had Hepatitis B or Hepatitis C in the past, you might still be able to join the study, but the doctor and the study sponsor would need to agree.Your organs must be working well when tested before starting the treatment.You have been taking strong medications that weaken your immune system within the last 14 days. If you've been taking low-dose corticosteroids, it's okay.You have taken a new medication within the last five times its half-life duration.You previously took immune checkpoint inhibitor medication but had to stop because of side effects.You have heart problems or other serious illnesses.You have had chemotherapy, targeted therapy, or immunotherapy within the last 4 weeks.You have severe neuropathy.You have recently had radiation treatment and have not fully recovered from any side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Part C Combination Therapy Dose Expansion
- Group 2: Part A Monotherapy Dose Escalation
- Group 3: Part B Combination Therapy 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.
Has the Food and Drug Administration ratified PT199 for public use?
"Due to the preliminary nature of this trial, our team at Power evaluated PT199's safety on a scale from 1 to 3 and gave it a score of 1. This is because Phase 1 trials typically have scant evidence backing their efficacy and safety."
Answered by AI
Are there any remaining vacancies within this trial for participants?
"Affirmative. The information on clinicaltrials.gov verifies that this medical study is actively enrolling patients, beginning from June 23rd 2022 and last revised on November 30th 2022. A total of 41 participants are being sourced across 3 different sites."
Answered by AI
What is the approximate size of the study population for this trial?
"Affirmative. Clinicaltrials.gov information indicates that this clinical trial, initially published on June 23rd 2022, is currently searching for participants to join in the study. 41 individuals need to be recruited from 3 medical sites."
Answered by AI
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