Solid Tumor / SI-B036 / Breast Cancer · Phase 1 Trial

A Study of SI-B036 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

ClinicalTrials.gov · August 7, 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 clinical trial registration for SI-B036, a bispecific antibody in development for locally advanced or metastatic breast cancer and solid tumors. The study is not yet recruiting and has not reported results; it is designed to establish dose-limiting toxicity, maximum tolerated dose, and recommended Phase 2 dose with preliminary efficacy assessment.

What was studied

Phase 1, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer, Solid Tumor; age from 18 Years; to 75 Years. Intervention: SI-B036. n = 39. 1 site: China.

Key findings

Safety

Study has not yet begun recruiting; no data on safety, tolerability, pharmacokinetics, or efficacy are available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 dose-escalation trial of a novel bispecific antibody in solid tumors; designed to establish safety and tolerability with preliminary efficacy assessment, not yet recruiting and results not reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Phase Ia: Dose limiting toxicity (DLT) (assessed at Up to 21 days after the first dose); Phase Ia: Maximum tolerated dose (MTD) (assessed at Up to 21 days after the first dose); Phase Ib: Recommended Phase II Dose (RP2D) (assessed at Up to approximately 24 months)

DesignPhase 1, Interventional, Single Group, Open label, Treatment purpose

PopulationBreast Cancer, Solid Tumor; age from 18 Years; to 75 Years

Sample size39

InterventionSI-B036

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Estimated enrollment39

Phase Ia primary outcome: Dose limiting toxicity (DLT)Up to 21 days after the first dose

Phase Ia primary outcome: Maximum tolerated dose (MTD)Up to 21 days after the first dose

Phase Ib primary outcome: Recommended Phase II Dose (RP2D)Up to approximately 24 months

Caveats

This is a registry record only; no results have been reported or analyzed.
Study has not yet begun recruiting; no data on safety, tolerability, pharmacokinetics, or efficacy are available.
Open-label design without blinding or randomization; Phase 1 primary purpose is dose escalation, not efficacy demonstration.
No comparator arm; preliminary efficacy is a secondary objective and cannot be assessed without published results.

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

moderate

Open-label, multicenter, dose-escalation and expansion design; Phase 1 structure appropriate for safety.

Directness

limited

Phase 1 focuses on safety and tolerability; efficacy preliminary only, not primary endpoint.

Consistency

insufficient

Registry record only; no comparator arm; no prior published data on SI-B036 cited.

Risk of bias

limited

Open-label design without blinding or randomization introduces detection bias risk.

Sample adequacy

limited

Estimated 39 participants across two phases; typical for Phase 1 but limited generalizability.

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 (NCT07753226). This is a study registration, not published results. Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 39 participants (ESTIMATED). Conditions: Breast Cancer, Solid Tumor. Interventions: DRUG: SI-B036. 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: Recommended Phase II Dose (RP2D) , Up to approximately 24 months. Brief summary: This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic breast cancer and other solid tumors.

Follow from this

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

NCT07753226Solid TumorSI-B036Breast CancerSichuan Baili Pharmaceutical Co.