A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors (NCT07300150) | Clinical Trial Compass
RecruitingPhase 1
A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
United States195 participantsStarted 2025-11-21
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women \>=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.
✓. 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
✕. 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:
✕. 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.
What they're measuring
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