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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

Must not have

Autoimmune disease requiring systemic treatment within the past twelve months

Patients who have received chemotherapy, ≤ 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosourea or mitomycin-C), targeted therapy, or immunotherapy within 4 weeks prior to starting study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of the study drug till 90 days after last dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, PT199, which helps the immune system fight advanced cancers that haven't responded to other treatments. PT199 blocks a protein that helps cancer cells hide, making it easier for the immune system to attack them, especially when combined with other immune-boosting drugs.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated for an autoimmune disease in the last year.

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I haven't had chemotherapy, targeted therapy, or immunotherapy in the last 4 weeks.

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I am a woman who can have children and do not use birth control.

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I do not have severe health issues like uncontrolled high triglycerides or infections that could make the trial unsafe for me.

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I have had lung inflammation treated with steroids or have a lung condition.

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I have severe nerve damage.

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I haven't had major radiation in the last 4 weeks or small area radiation in the last 2 weeks.

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I am not on warfarin or similar blood thinners, but other types are okay.

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I am not pregnant or breastfeeding.

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I am allergic to some cancer immunotherapy drugs or their ingredients.

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I have not had T-cell, NK cell, or CD73 inhibitor therapy but may have had PD-1 or PD-L1 inhibitors.

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I stopped immune therapy due to side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of the study drug till 90 days after last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of the study drug till 90 days after last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of the study drug till 90 days after last dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended Phase 2 Dose of PT199 as a single agent and/or in combination with a PD-1 inhibitor.

To determine the maximum tolerated dose (MTD), if reached.

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. 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

~4700

0 / 15Eligibility criteria met