BL-M07D1 / Ovarian Cancer / Endometrial Cancer · Phase 1 Trial

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 open-label study of BL-M07D1, a HER2-targeting agent, currently recruiting an estimated 280 participants across 10 solid tumour types. No efficacy or safety results are reported in this registry record; the study aims to establish maximum tolerated dose, maximum administered dose, and recommended doses for expansion over approximately 24 months.

What was studied

Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-j…; age from 18 Years. Intervention: Experimental: Dose Escalation; Experimental: Dose Finding; Experimental: Dose Expansion. n = 280. 26 sites: United States.

Key findings

Safety

Registry record only; no efficacy, safety or tolerability results are posted.

Who this may help

Clinicians should note this is an early-phase safety and dose-finding study with no results yet available. Until efficacy data are published, BL-M07D1 remains investigational.

Plain-language summary

This is a Phase 1 open-label trial still recruiting, with no results posted; it represents early-stage evaluation of a novel therapeutic agent.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Summary of safety (assessed at Though study completion, an average of 24 months); To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 (assessed at 21 Days)

DesignPhase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose

PopulationEndometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-j…; age from 18 Years

Sample size280

InterventionExperimental: Dose Escalation; Experimental: Dose Finding; Experimental: Dose Expansion

Setting26 sites: United States

Reported figures

Quoted from the source exactly as published.

PhasePHASE 1

Planned enrollment280

Study durationapproximately 24 months

Primary outcome measure 1Summary of safety through study completion, an average of 24 months

Primary outcome measure 221 Days

Clinical bottom line

Clinicians should note this is an early-phase safety and dose-finding study with no results yet available. Until efficacy data are published, BL-M07D1 remains investigational.

Caveats

Registry record only; no efficacy, safety or tolerability results are posted.
Open-label design without control arm; cannot quantify treatment effect.
Study currently recruiting; final enrollment and completion unknown.
Heterogeneous tumour types pooled; efficacy signals by cancer type not yet available.

Evidence assessment

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.

Study design

limited

Open-label Phase 1 design without control arm; vulnerable to bias.

Directness

moderate

Addresses safety and efficacy in HER2-expressing tumors; spans multiple cancer types.

Consistency

insufficient

Registry record; no results reported to assess consistency with other data.

Risk of bias

limited

Open-label design and lack of comparator introduce substantial bias risk.

Sample adequacy

insufficient

Enrollment estimated at 280; no published results available to confirm accrual.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06293898). This is a study registration, not published results. Lead sponsor: SystImmune Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 280 participants (ESTIMATED). Conditions: Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Esophageal Cancer. Interventions: DRUG: BL-M07D1. Primary outcome measures: Summary of safety , Though study completion, an average of 24 months; To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 , 21 Days. Brief summary: The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

SystImmuneNCT06293898BL-M07D1Ovarian CancerEndometrial CancerCervical Cancer