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NCT07861932
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
Conditions: Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 110
Sponsor: KymaThera, Inc.
Summary
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors. The study assesses the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of K-1728.
Eligibility Criteria
Key Inclusion Criteria:
* Adults with advanced or metastatic solid tumors who are able to provide consent
* Documented activating PIK3CA mutation
* ECOG performance status 0 or 1
* Adequate organ function
Key Exclusion Criteria:
* Active or untreated central nervous system disease
* Clinical significant or uncontrolled cardiovascular disease
* Significant or uncontrolled intercurrent illness
* Pregnant or breastfeeding
* Other protocol-defined exclusion criteria
Source: ClinicalTrials.gov (NCT07861932). StuddyBuddy aggregates publicly available trial information.
