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Recruiting
NCT07300150
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
Conditions: Colorectal Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer, Solid Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 210
Sponsor: PAQ Therapeutics, Inc.
Location: Dana-Farber/Massachusetts General Hospital, Inc Boston Massachusetts
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).
Eligibility Criteria
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 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 \
Source: ClinicalTrials.gov (NCT07300150). StuddyBuddy aggregates publicly available trial information.