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PD-1 Inhibitor

PT199 + Anti-PD-1 mAb for Cancer

Tranquility Research, Webster, TX
Targeting 6 different conditionsPT199 +1 morePhase 1RecruitingResearch Sponsored by Phanes Therapeutics

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 below
You are in good enough shape to perform daily activities without any problems, or with only a little trouble.
Your organs must be working well when tested before starting the treatment.
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.


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

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.

Find a Location

Who is running the clinical trial?

Phanes TherapeuticsLead Sponsor
2 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Anti-PD-1 monoclonal antibody (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05431270 — Phase 1
Pancreatic Adenocarcinoma Research Study Groups: Part C Combination Therapy Dose Expansion, Part A Monotherapy Dose Escalation, Part B Combination Therapy Dose Escalation
Pancreatic Adenocarcinoma Clinical Trial 2023: Anti-PD-1 monoclonal antibody Highlights & Side Effects. Trial Name: NCT05431270 — Phase 1
Anti-PD-1 monoclonal antibody (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05431270 — Phase 1

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
~17 spots leftby Dec 2024