> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-pt0511-in-participants-with-kras-mutated-or-34c0f37b-2872-47ea-b68a-a2bfe87979ba > Record changed: 2026-10-13 # A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors NCT07300150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Participants 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Lead sponsor PAQ Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Start date 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Short title** A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Official title** A Phase 1, Open-label Dose Escalation and Expansion Study Of PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Dates **Completion date** 2028-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **First posted** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Registry last updated** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Primary completion date** 2028-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Start date** 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Size and sites **Participants** 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Planned participants** 210 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Lead sponsor** PAQ Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Identifiers **Registry ID** NCT07300150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **ClinicalTrials.gov ID** NCT07300150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Outcomes ### Primary outcomes 1. Number of Participants with Dose-limiting Toxicities (DLT) Timeframe: Cycle 1 (Cycle length=21 days) 2. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Timeframe: Up to 24 months 3. Number of Participants with TEAEs Leading to Treatment Interruptions, Dose Reductions and Permanent Discontinuations Timeframe: Up to 24 months ### Secondary outcomes 1. Cmax/C0: Maximum Blood Concentration (Cmax) and/or Concentration at Time 0 (C0) of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 2. Tmax: Time to Reach Cmax of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 3. AUC0-t: Area Under the Curve From time 0 to the time of the Last Quantifiable Concentration of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 4. t1/2: Terminal Elimination Half-life of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 5. AUC0-∞: Area Under the Curve From Time 0 Extrapolated to Infinity of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 6. CL: Clearance of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 7. Vd: Volume of Distribution of PT0511 Timeframe: Cycle 1 Days 1 and 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 8. Overall Response Rate (ORR) Timeframe: Up to 12 months ORR will be determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 9. Duration of Response (DOR) Timeframe: Up to 12 months DOR will be determined by radiographic disease assessments per RECIST 1.1. 10. Number of Participants with Antitumor Activity Markers in Peripheral Blood of PT0511 Timeframe: Cycle 1 Day 15: Pre-infusion and up to 24 hours post-infusion (Cycle length=21 days) 11. Overall Survival (OS) Timeframe: At 1 year OS is defined as the time from enrollment up to death due to any cause. 12. Progression-free Survival (PFS) Timeframe: At 1 year PFS will be determined by radiographic disease assessments per RECIST 1.1. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria Cancer History - 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 Prior Cancer Therapy - 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 Medical History - 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 Medications • Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, Use of a strong P-gp inhibitor or inducer Organ Function • Participants with laboratory values indicating inadequate hematology, hepatic, or renal function Diagnostic Assessments - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Sites - Dana-Farber/Massachusetts General Hospital, IncBoston, United StatesRecruiting - New Experimental Therapeutics of San Antonio LLCSan Antonio, United StatesRecruiting - START - South Texas Accelerated Research Therapeutics, LLCSan Antonio, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Samsung Medical CenterSeoul, South KoreaRecruiting - Seoul National University Bundang HospitalSeoul, South KoreaRecruiting - Seoul National University HospitalSeoul, South KoreaRecruiting - Severance Hospital, Yonsei University Health SystemSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300150) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [PAQ Therapeutics, Inc.](https://trialight.com/data/company/paq-therapeutics-inc-e909a877-bce3-482c-917e-b0ef609ffa55.md) ### Conditions (4) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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