Actively Recruiting
PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
Led by Pyrotech Therapeutics, Inc. · Updated on 2025-03-12
68
Participants Needed
3
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1/L1 therapy in patients suitable for anti- PD-1/L1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.
CONDITIONS
Official Title
PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness and ability to adhere to all study procedures
- Male or female aged 18 years or older
- Confirmed locally advanced unresectable or metastatic solid tumor by histology or cytology
- For Phase 1: tumor measurable or unmeasurable by RECIST v1.1 and iRECIST; for Phase 2a: at least one measurable tumor by RECIST v1.1 and iRECIST
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and blood function within 7 days before first dose, including neutrophil count ≥ 1.5 x10^9/L without recent G-CSF, platelet count ≥ 90 x10^9/L without recent transfusion, hemoglobin ≥ 90 g/L with or without treatment, creatinine clearance ≥ 60 mL/min, liver enzymes ≤ 3 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit of normal, and appropriate coagulation parameters depending on anticoagulation status
You will not qualify if you...
- Presence of leptomeningeal metastases or new/progressive brain metastases unless treated and stable for at least 4 weeks
- History of other primary cancers not in remission for at least 3 years except certain treated skin, cervical, prostate, melanoma, or thyroid cancers
- Ongoing adverse effects from prior cancer treatments not resolved to mild levels except alopecia and hypothyroidism, or history of severe immune-related adverse events or CNS toxicity from immunotherapy
- Active or history of autoimmune diseases prone to relapse except well-controlled hypothyroidism
- Major surgery or trauma within 4 weeks before study start or planned during study
- Serious unhealed wounds, ulcers, or bone fractures
- Recent major cardiovascular events, significant ECG abnormalities, heart failure stage II-IV, low heart function, or other serious heart diseases
- Uncontrolled high blood pressure despite treatment
- Active or recent bleeding disorders within 6 months
- Uncontrolled diabetes
- Severe chronic liver disease or advanced liver cirrhosis
- History of alcoholism or drug abuse within the past year
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
2
D&H Cancer Research Center
Margate, Florida, United States, 33063
Actively Recruiting
3
The START Center
San Antonio, Texas, United States, 78229
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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