Actively Recruiting
A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
Led by PAQ Therapeutics, Inc. · Updated on 2025-12-18
115
Participants Needed
7
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
CONDITIONS
Official Title
A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Documented KRAS p.G12D mutation by validated molecular testing
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Willingness to avoid pregnancy or fathering children from screening through 90 days after last study treatment dose
You will not qualify if you...
- Active brain metastasis or carcinomatous meningitis, unless treated and stable with no new lesions
- History of other malignancies within 2 years except certain low-risk, treated cancers
- Unresolved toxicities from prior anticancer therapies greater than grade 1 except alopecia
- Participation in another interventional clinical study
- Recent treatment with anticancer or investigational drugs within 14-28 days or 5 half-lives
- Significant cardiovascular disease within 6 months before study treatment
- Active infection requiring antibiotics within 1 day of treatment
- Known HIV infection with low CD4 count or on certain antiretroviral therapies
- History of drug-induced liver injury or significant liver disease
- Major surgery within 4 weeks or complications preventing study adherence
- Known allergy to study products
- Conditions affecting ability to consent or comply with study procedures
- Use of certain CYP3A4/5 or drug transporter inhibitors, inducers, or substrates during dose escalation
- Abnormal laboratory values indicating inadequate blood, liver, or kidney function
- Abnormal resting ECG or prolonged QTcF interval (>=450 msec)
- Female pregnancy or lactation through 28 days after last dose
- Active hepatitis B or C infection unless resolved or stably treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Dana Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
SCRI Lake Mary
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
New Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
5
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
6
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
7
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
P
PAQ Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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