PTT-936 Dose Level 2 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Pyrotech Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients ≥ 18 years of age at the time of signing the ICF

Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months

Awards & highlights

Study Summary

This trial will test a new drug called PTT-936, which activates ALPK1, in patients with advanced solid tumors. The study has two parts: Phase 1 will determine the safe dosage

Who is the study for?

Adults over 18 with advanced solid tumors that can't be surgically removed or have spread, who are able to follow the study plan. They should not need constant blood cell growth support and must have a life expectancy of at least 3 months. Their physical condition should allow normal activity or light work.Check my eligibility

What is being tested?

The trial is testing PTT-936 alone or combined with anti-PD-1/L1 therapy in two phases. Phase 1 finds the right dose and checks safety when used alone, while Phase 2a tests its effectiveness and safety when combined with anti-PD-1/L1 therapy against tumor growth.See study design

What are the potential side effects?

Specific side effects for PTT-936 aren't listed but may include typical reactions to cancer therapies such as fatigue, nausea, immune-related issues due to anti-PD-1/L1 drugs, and potential risks associated with new experimental treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older.

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My cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of TEAEs and TRAEs (with severity determined using NCI CTCAE v5.0), Grade >3 TEAEs, Grade >3 TRAEs, SAEs, and AESIs

Overall Response Rate (ORR): defined as the percentage of patients who achieved Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 and iRECIST during the study

Trial Design

10Treatment groups

Experimental Treatment

Group I: PTT-936 and anti-PD-1/L1 combination therapyExperimental Treatment1 Intervention

PTT-936 to be administered every other day (QOD) in combination with a standard-of-care (SOC) regimen of an anti-PD-1/L1 agent every three weeks (Q3W)

Group II: PTT-936 Dose Level 9Experimental Treatment1 Intervention