PT0511 for Advanced Solid Tumors with KRAS Mutation or Amplification
This study is testing a new drug called PT0511, alone or with cetuximab, for people with advanced solid tumors that have a specific genetic change called a KRAS mutation or amplification. This includes colorectal cancer, pancreatic cancer, and non-small cell lung cancer. The main goals are to find out how safe PT0511 is, what side effects it might cause, and the best dose to use. You might be able to join if you are 18 or older and have one of these cancers with a KRAS mutation or amplification. The current status of this study is unclear, but it plans to enroll about 210 participants.
- Study design
- This study is testing the drug PT0511 alone and in combination with cetuximab. It plans to enroll about 210 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-emergent adverse events (side effects) for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07300150
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentPAQ Therapeutics, Inc.
~210 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:PT0511Cetuximab
At a glance
Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-limiting Toxicities (DLT)
Measured over Cycle 1 (Cycle length=21 days)
+2 more outcomes measured
Conditions
Where it's being run
9 sites across 5 statesSouth Korea4
Texas2
Massachusetts1
Utah1
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Men or women less than or equal to (\>=) 18 years of age
Histologically or cytologically confirmed advanced or metastatic solid malignancy
Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test
Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit
Measurable disease (RECIST 1.1 Criteria)
ECOG Performance Status 0 or 1
Willingness to avoid pregnancy or fathering children screening through 90 days after the last dose of study treatment
Exclusion
Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade \<=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain MRI documents no new/worsening brain lesions
History of any other malignancy within the past 2 years, except:
Malignancy treated with curative intent and with no known active disease present \>=2 years before enrolment and felt to be at low risk for recurrence by the investigator
Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast
Unresolved toxicities from prior anti-cancer therapies. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy
Concurrent participation in another interventional clinical study.
Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
At least 14 days for chemotherapy or targeted small-molecule therapy
At least 28 days for a prior monoclonal antibody
At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. For drugs with very long half-lives, participants may be allowed to enroll prior to 5 half-lives at the discretion of the investigator in discussion with the medical monitor
Note: Concurrent hormonal therapy for prostate or breast cancer is allowable
Prior treatment with a KRAS/RAS degrader
Significant cardiovascular disease within 6 months of starting study therapy
Active infection requiring antibiotics within 7 days of study treatment.
Known HIV infection with a CD4+ T-cell count \<200 cells/mcL and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate CYP3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment
Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures
Known hypersensitivity to any of the products to be administered during dosing
Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures
Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG
Baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) \>=470 msec
Female participants of childbearing age with a positive urine or serum test within 7 days of study start or confirmation from Ob/Gyn that any positive bHCG test is not representative of an ongoing pregnancy
Women who are lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug
Active HBV infection. Participants with resolved infection or who are on Stable antiviral therapy are eligible
Active HCV infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible
What this trial measures
- Number of Participants with Dose-limiting Toxicities (DLT)Cycle 1 (Cycle length=21 days)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)Up to 24 months
- Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent DiscontinuationsUp to 24 months