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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
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 belowSelect...
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:Select...
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
Treatment Details
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
PTT-936 will be administered every other day (QOD)
Group III: PTT-936 Dose Level 8Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group IV: PTT-936 Dose Level 7Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group V: PTT-936 Dose Level 6Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group VI: PTT-936 Dose Level 5Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group VII: PTT-936 Dose Level 4Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group VIII: PTT-936 Dose Level 3Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group IX: PTT-936 Dose Level 2Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Group X: PTT-936 Dose Level 1Experimental Treatment1 Intervention
PTT-936 will be administered every other day (QOD)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors often include immunotherapy and kinase inhibitors. Immunotherapy, such as anti-PD-1/PD-L1 therapy, works by stimulating the immune system to recognize and attack cancer cells, which can be particularly effective in tumors that evade immune detection.
Kinase inhibitors, like the ALPK1 activator PTT-936, target specific enzymes involved in cancer cell growth and survival, disrupting signaling pathways that tumors rely on. These treatments are significant for solid tumor patients as they offer targeted approaches that can improve outcomes and reduce side effects compared to traditional chemotherapy.
A new antisarcoma strategy: multisubtype heat shock protein/peptide immunotherapy combined with PD-L1 immunological checkpoint inhibitors.Correlation between ERK1 and STAT3 expression and chemoresistance in patients with conventional osteosarcoma.
A new antisarcoma strategy: multisubtype heat shock protein/peptide immunotherapy combined with PD-L1 immunological checkpoint inhibitors.Correlation between ERK1 and STAT3 expression and chemoresistance in patients with conventional osteosarcoma.
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Who is running the clinical trial?
Pyrotech Therapeutics, Inc.Lead Sponsor
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