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BL-M07D1 / Locally Advanced Or Metastatic Solid Tumor / Breast Cancer · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for BL-M07D1, a novel therapeutic agent, designed to evaluate dose-limiting toxicity, maximum tolerated dose, and recommended Phase 2 dose in patients with HER2-positive/negative breast cancer and other solid tumors. No results have been posted to the registry; the trial is currently recruiting.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer, Locally Advanced or Metastatic Solid Tumor; age from 18 Years; to 75 Years. Intervention: Study treatment. n = 348. 7 sites: China.
This is a Phase 1 clinical trial registration for BL-M07D1, a novel therapeutic agent, designed to evaluate dose-limiting toxicity, maximum tolerated dose, and recommended Phase 2 dose in patients with HER2-positive/negative breast cancer and other solid tumors. No results have been posted to the registry; the trial is currently recruiting.
This is a registry record only; no safety, tolerability, or efficacy results are reported. Primary outcomes are dose-finding and safety; clinical efficacy data will not be available until Phase 2.
The source did not state who this applies to in practice.
This is a Phase 1 trial registration with no results reported; it describes a planned dose-escalation and safety study in an early stage of drug development.
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 (NCT05461768). This is a study registration, not published results. Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 348 participants (ESTIMATED). Conditions: Breast Cancer, Locally Advanced or Metastatic Solid Tumor. Interventions: DRUG: BL-M07D1. Primary outcome measures: Phase Ia: Dose limiting toxicity (DLT) , Up to 21 days after the first dose; Phase Ia: Maximum tolerated dose (MTD) , Up to 21 days after the first dose; Phase Ib: Phase II clinical study recommended dose (RP2D) , Up to 21 days after the first dose. Brief summary: In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients
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