A prospective, single-arm, multicenter phase 2 trial is now recruiting to assess the efficacy and safety of iparomlimab/tuvonralimab (QL1706) combined with paclitaxel and carboplatin in the neoadjuvant setting for HR+/HER2− breast cancer. The study is being conducted at RenJi Hospital.
A phase 2 interventional trial (NCT07396324) is actively enrolling participants to investigate the neoadjuvant use of QL1706—a bispecific antibody co-targeting PD-1 and CTLA-4 via its components iparomlimab and tuvonralimab—in combination with paclitaxel and carboplatin for hormone receptor-positive, HER2-negative breast cancer. The open-label, single-arm design will evaluate both antitumor efficacy and the safety profile of this regimen prior to definitive surgery.
HR+/HER2− breast cancer has historically shown limited responsiveness to immune checkpoint blockade compared with triple-negative subtypes, making the exploration of dual checkpoint inhibition in this population clinically noteworthy. QL1706's simultaneous blockade of PD-1 and CTLA-4 pathways may augment immunogenic priming when combined with cytotoxic chemotherapy, potentially improving pathologic complete response rates in a subgroup where neoadjuvant immunotherapy has not yet demonstrated clear benefit.
The trial is being conducted across multiple centers with RenJi Hospital as a participating site. As a single-arm design without a comparator cohort, interpretation of efficacy outcomes will require contextualization against historical benchmarks for neoadjuvant chemotherapy in HR+/HER2− disease. Full eligibility criteria, primary endpoints, and enrollment targets have not been detailed in the available registration data.
Key points
- NCT07396324 is a recruiting, open-label, single-arm phase 2 trial of neoadjuvant QL1706 (iparomlimab + tuvonralimab) plus paclitaxel and carboplatin in HR+/HER2− breast cancer.
- QL1706 is a bispecific agent with dual PD-1 and CTLA-4 inhibitory activity, representing a novel immunotherapeutic approach in a subtype less responsive to checkpoint monotherapy.
- The neoadjuvant setting allows pathologic response assessment as a potential surrogate endpoint for long-term outcomes.
- The single-arm design limits direct comparative efficacy conclusions; results will need to be interpreted against historical neoadjuvant chemotherapy data.
- The trial is multicenter and prospective, with RenJi Hospital among the participating institutions.
Why it matters
HR+/HER2− breast cancer remains an underserved subtype for immunotherapy development; this trial tests whether dual PD-1/CTLA-4 blockade can meaningfully augment neoadjuvant chemotherapy response in a population where checkpoint inhibitors have shown limited single-agent activity. Findings could inform future combination strategies and expand the immunotherapy-eligible breast cancer population.