Actively Recruiting
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
Led by PAQ Therapeutics, Inc. · Updated on 2026-05-07
195
Participants Needed
5
Research Sites
151 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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
CONDITIONS
Official Title
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 years of age or older
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Documented KRAS mutation or wild-type KRAS amplification by molecular testing
- Received at least 1 and no more than 4 prior systemic therapies or intolerant/ineligible for available treatments
- Measurable disease according to RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1
- Willing to avoid pregnancy or fathering children through 90 days after last study treatment dose
You will not qualify if you...
- Active brain metastasis or carcinomatous meningitis unless stable and meeting specific criteria
- History of other malignancies within past 2 years except certain treated low-risk cancers
- Unresolved toxicities from prior anticancer therapies except for endocrine replacement therapies
- Participation in another interventional clinical study
- Recent anticancer medications or investigational drugs within specified intervals before study drug
- Prior treatment with a KRAS/RAS degrader
- Significant cardiovascular disease within 6 months before study therapy
- Active infection requiring antibiotics within 7 days before treatment
- Known HIV infection with low CD4 count or on certain antiretroviral regimens
- History of drug-induced liver injury or specific liver diseases
- Major surgery within 4 weeks before study therapy or unresolved postoperative complications
- Known hypersensitivity to study products
- Any disorder compromising informed consent or study compliance
- Use of strong or moderate CYP3A4/5 or P-gp inhibitors or inducers in dose escalation part
- Inadequate hematology, liver, or kidney function by lab tests
- Clinically significant ECG abnormalities or QTcF ≥470 msec
- Positive pregnancy test or lactating/breastfeeding women
- Active hepatitis B or C infection unless stable or treated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Dana-Farber/Massachusetts General Hospital, Inc
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
New Experimental Therapeutics of San Antonio LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
3
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
4
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
5
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
9
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