What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as kinase inhibitors and immune checkpoint inhibitors, have a range of side effects. Kinase inhibitors can cause hypertension, diarrhea, liver enzyme abnormalities, and fatigue. Immune checkpoint inhibitors may lead to immune-related adverse events like colitis, dermatitis, hepatitis, and endocrinopathies. These side effects are typical for therapies targeting solid tumors, including those similar to the ALPK1 activator being studied in the PTT-936 trial.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve kinase inhibitors and immune checkpoint inhibitors. For instance, tyrosine kinase inhibitors like pazopanib and eribulin have been approved for soft tissue sarcomas. Immune checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab have been approved for various solid tumors, including non-small cell lung cancer and renal cell carcinoma. These treatments often target pathways similar to those being investigated with PTT-936, particularly when combined with anti-PD-1/L1 therapies.

What other types of research exist?

Promising novel alternatives to PTT-936 for solid tumor patients include: 1) Avelumab plus Axitinib, which has shown efficacy in advanced renal cell carcinoma, 2) Atezolizumab plus Bevacizumab, which has demonstrated positive results in metastatic renal cell carcinoma, and 3) Pembrolizumab monotherapy, which has been effective as a first-line therapy in various advanced renal cell carcinoma subtypes.

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Combination Therapy

PTT-936 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

Must not have

Patients with leptomeningeal (LMD) metastases or patients with new and/or progressive brain metastases at the time of study entry

History of primary malignancy other than the diseases under study, not in remission greater than three (3) years prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called PTT-936, which helps activate a protein to control tumor growth. It targets patients with advanced or spreading tumors. The drug may work better when combined with another treatment that boosts the immune system.

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.

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.

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.

Exclusion Criteria

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

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I have cancer that has spread to the lining of my brain or spinal cord or new brain tumors.

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I have had cancer other than the one being studied, but it has been in remission for over 3 years.

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I haven't had major surgery or trauma in the last 4 weeks and don't expect any during the study.

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I do not have uncontrolled high blood pressure, recent severe bleeding, uncontrolled diabetes, severe liver disease, or a history of substance abuse in the past year.

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I have an active autoimmune disease or a history of one that might come back.

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I have a history of heart or brain blood flow problems.

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I still have side effects from cancer treatment that are not mild.

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I have a serious wound, ulcer, or bone fracture that is not healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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