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LOXO-783 / Abemaciclib / Imlunestrant · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for LOXO-783, a putative PIK3CA inhibitor, in patients with breast cancer and other solid tumors. No results have been posted to the registry; the study is currently recruiting and designed to determine maximum tolerated dose and dose-limiting toxicities over a 28-day cycle, with participation potentially extending to 36 months or longer.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Breast Cancer; age from 18 Years. Intervention: Phase 1A: LOXO-783 Monotherapy Dose Escalation; Phase 1B: Part A; Phase 1B: Part B; Phase 1B: Part C; Phase 1B: Part D; Phase 1B: Part E; Phase 1B: Part F. n = 260. 50 sites across 12 countries.
This is a Phase 1 clinical trial registration for LOXO-783, a putative PIK3CA inhibitor, in patients with breast cancer and other solid tumors. No results have been posted to the registry; the study is currently recruiting and designed to determine maximum tolerated dose and dose-limiting toxicities over a 28-day cycle, with participation potentially extending to 36 months or longer.
Study is actively recruiting; Phase 1 trials are designed for dose escalation and safety, not efficacy assessment.
This is a safety and tolerability study; no efficacy data are available. Clinicians should await Phase 1 results and downstream trials before considering LOXO-783 for patient care.
Phase 1 trial registration with no posted results; study is actively recruiting and designed to establish safety and tolerability rather than efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This is a safety and tolerability study; no efficacy data are available. Clinicians should await Phase 1 results and downstream trials before considering LOXO-783 for patient care.
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.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05307705). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 260 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: LOXO-783; DRUG: Fulvestrant; DRUG: Imlunestrant; DRUG: Abemaciclib; DRUG: Anastrozole, Exemestane, or Letrozole; DRUG: Paclitaxel. Primary outcome measures: Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) , During the first 28-day cycle of LOXO-783 treatment; Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities , During the first 28-day cycle of LOXO-783 treatment. Brief summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.