Trial Registered

Chia Tai Tianqing registers dose-finding trial of TQB3126 in breast cancer

The Phase 1/2 study will test safety and an early dose before any efficacy signal can inform the crowded HER2, TROP2 and PD-1/PD-L1 breast cancer field.

By AppliedXLJuly 13, 2026Trial NCT07697443

Executive Summary

Chia Tai Tianqing Pharmaceutical Group has registered a new dose-finding trial for an oral or systemic agent in breast cancer patients who progressed on prior treatment, opening a multi-year path toward a first readable signal.
The design prioritizes safety, tolerability and dose selection over a defined efficacy bar, so the earliest disclosures will describe tolerability and a preliminary response signal rather than a decisive comparative result.
The trial enters a breast cancer field where multiple mechanistically distinct, later-stage programs from larger sponsors are already advancing, meaning the asset's differentiation will need to be established later rather than assumed at registration.
The sponsor's own track record in the disease area is established, and its typical protocol stability supports a normal expectation for how this early trial will run, without any operational irregularity to flag today.

The registration

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has registered NCT07697443, a Phase 1/2, open-label, multicenter, non-randomized study of TQB3126 in patients with histopathologically confirmed breast cancer who have documented disease progression during or after their most recent systemic therapy. The trial plans to enroll 306 patients across six sites in China, with a projected start date of August 1, 2026, and an anticipated primary completion date of August 1, 2029. The study has not yet begun recruiting. NCT07697443+1

What the trial will measure

The registered primary outcomes center on dose-finding and safety: dose-limiting toxicity through the end of the first roughly 35-day treatment cycle, maximum tolerated dose, the recommended Phase II dose, and the incidence and severity of adverse events and serious adverse events. Objective response rate per RECIST v1.1 is also listed as a primary measure, tracked from first dose until documented progression over as long as three years. Secondary measures cover pharmacokinetic parameters (clearance, half-life, peak concentration) alongside disease control rate, duration of response and progression-free survival. That structure is standard for an early dose-escalation and expansion design: the trial is built to establish tolerability and a workable dose before any efficacy claim can be made. NCT07697443

The competitive field

TQB3126's target and mechanism of action are not established in available records, so no target-based comparison to rival programs can be drawn. The breast cancer trial field around it is populated by mechanistically distinct, later-stage programs: Merck's sacituzumab tirumotecan and patritumab deruxtecan (both antibody-drug conjugates), Daiichi Sankyo's trastuzumab deruxtecan, Novartis's ribociclib (a CDK4/6 inhibitor), and Shanghai JMT-Bio's anbenitamab, all in Phase 3 testing across various breast cancer subtypes. None of these share a confirmed target or mechanism class with TQB3126, so the field is best read on modality and phase alone: a dense set of validated mechanisms (HER2-directed ADCs, PD-1/PD-L1 blockade, CDK4/6 inhibition) already advancing toward or through registrational trials, against which an early, mechanistically unclassified entrant has yet to generate any data of its own. NCT07697443

Sponsor track record

Chia Tai Tianqing carries an established breast cancer trial history, with a completion rate cited at 86% across seven prior breast cancer studies. Across its full portfolio the company has run 382 trials, completing 75 with a 71% overall completion rate and 30 terminated. The trial's registry-churn profile is currently stable, with no protocol amendments recorded since registration. Those figures describe a sponsor with a 71% completion rate across 382 prior oncology trials, not a risk indicator for this specific trial, which has not yet opened enrollment. NCT07697443

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.