NCT06244992 · Pyrotech Therapeutics, Inc.
PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
What this study is about
This Phase 1/2a study will explore the safety and effectiveness of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors.
View original scientific description
This Phase 1/2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1/L1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy.
Interventions
DRUG
PTT-936
Eligible patients will receive single-agent PTT-936 administered per orally (PO).
DRUG
Combination of PTT-936 and anti-PD-1/L1 therapy
Eligible patients will receive combination treatment consisting of PTT-936 administered PO in combination with a Standard of Care (SOC) regimen of an anti-PD-1/L1 agent administered intravenously (IV).
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
Time frame: 7 months
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
Time frame: 7 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Voluntarily signed informed consent form (ICF). 2. Ability and willingness to adhere to all study procedures. 3. Male or female patients ≥ 18 years of age at the time of signing the ICF. 4. Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology 5. For Part A: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with measurable or unmeasurable disease. For Part B: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with at least one measurable disease. 6. Life expectancy ≥ 3 months. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 for Part A and Part B. 8. Adequate end-organ and hematopoietic function, defined based on the following laboratory results obtained within 7 days prior to the first dose of study treatment \[Day 1\]): 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L (1500/μL), without granulocyte colony-stimulating factor (G-CSF) support. Note that G-CSF may be administered until
Where
- Beverly Hills, California
- Margate, Florida
- San Antonio, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2025 · Source of record for eligibility and locations