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PD-1 Inhibitor
PT199 + Anti-PD-1 for 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
Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (archival tissue or fresh biopsy). To be assessed for CD73 and other biomarkers (PD-L1) expression
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years.
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after standard treatments or when such treatments aren't suitable. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but can do light work, and be able to provide tissue samples. Pregnant women, those with certain medical conditions, or who've had recent treatments excluded by the trial's criteria cannot participate.Check my eligibility
What is being tested?
PT199 (an Anti-CD73 mAb) alone and combined with a PD-1 inhibitor are being tested in patients with advanced cancers. The study will assess safety, tolerability, how the body processes these drugs, their effects on the body and initial effectiveness against cancer progression.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, fatigue, immune-related issues like inflammation of organs due to an overactive immune response which may require steroids for management; specific side effect profiles will be monitored closely given this is a first-in-human study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tissue sample for cancer biomarker testing.
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I am fully active or can carry out light work.
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My biopsy was not just a needle aspiration.
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
Dose Limiting Toxicity (DLT)
Evaluate the safety of PT199
Maximum Tolerated Dose (MTD), if reached.
+1 moreSecondary outcome measures
Pharmacokinetics of PT199
Preliminary Efficacy (assessed by the response rate by iRECIST and RECIST 1.1).
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.
A minimum of 14 evaluable patients should be treated at DRDE before it can be declared as Recommend Phase II dose (RP2D). These can include the evaluable patients who were treated at DRDE in the dose escalation cohort(s). The RP2D may be declared based on the totality of safety, pharmacokinetics, and efficacy data from the dose escalation and dose expansion cohort, and upon the consensus of the Investigator(s), medical monitor, and Sponsor.
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 10 mg/kg weekly (QW). The dose level of PD-1 inhibitor, Tislelizumab 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for an autoimmune disease in the last year.I have another cancer, but it's either not spreading or doesn't need treatment right now, except for skin or cervical cancers that were treated.I can provide a tissue sample for cancer biomarker testing.You have taken a new medication within a certain time period.My brain metastases are stable, and I haven't used corticosteroids for 28 days.I haven't had a live-virus vaccine in the last 30 days, except for the Janssen COVID-19 vaccine.I had major surgery less than 4 weeks ago or haven't recovered from past treatment side effects.You have been diagnosed with HIV, but if your HIV is well controlled, you might be able to join if the doctor and the people running the study agree.I am over 18 and can follow the study's requirements.I haven't had chemotherapy, targeted therapy, or immunotherapy in the last 4 weeks.I have severe nerve damage.I have had lung inflammation treated with steroids or have a lung condition.I am a woman who can have children and do not use birth control.I have Hepatitis B or C that is not under control, but my doctor might still consider me.I do not have severe health issues like uncontrolled high triglycerides or infections that could make the trial unsafe for me.You have at least one tumor that can be measured according to specific guidelines.I haven't had major radiation in the last 4 weeks or small area radiation in the last 2 weeks.I agree to use highly effective birth control during and 6 months after the study.I am not on warfarin or similar blood thinners, but other types are okay.All my side effects from previous cancer treatments are mild or gone, except for hair loss or nerve issues.I am not pregnant and have had a negative pregnancy test within the last 72 hours.My advanced cancer has not responded to standard treatments, or I can't tolerate them.I can choose whether to have a biopsy in the first part of the trial.I do not have significant heart problems.I am not pregnant or breastfeeding.I am fully active or can carry out light work.My biopsy was not just a needle aspiration.I am allergic to some cancer immunotherapy drugs or their ingredients.I have not had T-cell, NK cell, or CD73 inhibitor therapy but may have had PD-1 or PD-L1 inhibitors.My organs are working well, as confirmed by recent tests.I haven't taken strong immune system medications, except for low-dose steroids, in the last 2 weeks.I stopped immune therapy due to side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Part B Combination Therapy Dose Escalation
- Group 2: Part A Monotherapy Dose Escalation
- Group 3: Part C Combination Therapy Dose Expansion
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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