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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07861932). This is a study registration, not published results. Lead sponsor: KymaThera, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 110 participants (ESTIMATED). Conditions: Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation. Interventions: DRUG: K-1728; DRUG: Fulvestrant; DRUG: Palbociclib. Primary outcome measures: Maximum Tolerated Dose (MTD)/Maximum Efficacious Dose (MED) and Recommended Phase 2 Dose (RP2D) , Cycle 1 (28 days) through completion of dose escalation (up to approximately 24 months); Incidence of Dose-Limiting Toxicities (DLTs) , Initiation of study drug through Cycle 1 (28 days); Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) , From first dose through 30 days after the last dose of study treatment (up to approximately 24 months); Changes in laboratory parameters , From first dose through 30 days after the last dose of study treatment (up to approximately 24 months); Changes in vital signs , From first dose through 30 days after the last dose of study treatment (up to approximately 24 months); Changes in electrocardiogram (ECG) parameters , From first dose through 30 days after the last dose of study treatment (up to approximately 24 months); Changes in physical examination , From first dose through 30 days after the last dose of study treatment (up to approximately 24 months). Brief 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.