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AL8326 / Eribulin / Breast Neoplasms · Phase 1/2 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1b/2a study evaluating AL58805 (a PI3K/mTOR inhibitor) in combination with three different anticancer agents across four gynecologic, soft tissue, and breast malignancies. The trial has not yet begun recruitment and no efficacy or safety results are available from this registry record.
Phase 1/2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Endometrial Neoplasms, Soft Tissue Sarcoma (STS), Breast Neoplasms; age from 18 Years. Intervention: P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS ca…; P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Brea…; P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Canc…; P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical…. n = 138. 1 site: United States.
This is a planned Phase 1b/2a study evaluating AL58805 (a PI3K/mTOR inhibitor) in combination with three different anticancer agents across four gynecologic, soft tissue, and breast malignancies. The trial has not yet begun recruitment and no efficacy or safety results are available from this registry record.
No safety, efficacy, or pharmacokinetic data available to inform clinical practice.
The source did not state who this applies to in practice.
This is a Phase 1b/2a trial registry record with no results posted; it describes a planned study design and enrollment strategy only.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT07811232). This is a study registration, not published results. Lead sponsor: Advenchen Pharmaceuticals, LLC.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 138 participants (ESTIMATED). Conditions: Endometrial Neoplasms, Soft Tissue Sarcoma (STS), Breast Neoplasms. Interventions: DRUG: AL58805; DRUG: AL8326; DRUG: Eribulin; DRUG: Fulvestrant. Primary outcome measures: Recommended Combination Dose (RCD) , 36 months; Objective Tumor Response Rate (ORR) , 36 months. Brief summary: This phase 1b/2a study evaluates AL58805, an oral investigational drug that blocks PI3K and mTOR signaling, in combination with one of three anticancer treatments: AL8326 (veonetinib), eribulin, or fulvestrant. Adults with recurrent, advanced, or metastatic endometrial cancer, cervical cancer, soft tissue sarcoma, or breast cancer may be eligible after at least one prior standard treatment has failed or could not be tolerated and no effective standard treatment option remains. In phase 1b, small groups of participants will receive different doses of AL58805 with a fixed dose of the partner treatment to identify a recommended combination dose based on dose-limiting side effects. In phase 2a, disease-specific groups will receive the selected combination dose to estimate the objective response rate and further evaluate duration of response, progression-free survival, overall survival, safety, pharmacokinetics, and exploratory tumor biomarkers. Protocol treatment may continue for up to 12 months, with continued treatment beyond 12 months possible for participants who remain clinically benefiting and receive investigator and sponsor approval.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.