NCT07256236

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer

A Single-arm, Multicenter, Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With QL1706 for Recurrent or Metastatic Cervical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer.

Detailed description

Cervical cancer (CC) is a major global health concern. Current second-line options, including single-agent chemotherapy or PD-1/L1 inhibitors, provide limited benefit, with objective response rates (ORR) of only 5-29%. Patients with cervical adenocarcinoma, which constitutes 20-25% of cases, often have a poorer prognosis, and no specific treatments are recommended for this subtype. QL1706, a novel dual anti-PD-1/CTLA-4 antibody, has been approved in China for the second-line treatment of CC. Separately, TROP2 is highly expressed in 88.7% of CC and is associated with poor prognosis. Sac-TMT, a TROP2-directed ADC, combined with an anti-PD-1 agent showed a promising ORR of 57.9% in a phase II study, without new safety signals. Based on the unique mechanisms of action of Sac-TMT and QL1706, as well as the existing research data, their combination is expected to provide a better second-line treatment option for recurrent or metastatic CC. Therefore, we are applying to conduct this Phase II, multicenter, single-arm clinical study to evaluate the efficacy and safety of Sac-TMT in combination with QL1706 for the treatment of recurrent or metastatic CC, in order to improve clinical benefits for patients.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab tirumotecan	intravenous (IV) infusion (4mg/kg, Q2W)
DRUG	QL1706	intravenous (IV) infusion (3mg/kg, Q2W). Continuous administration will be maintained until radiological disease progression, occurrence of intolerable toxicity, the participant requests to discontinue treatment, or other treatment discontinuation criteria specified in the protocol are met (whichever occurs first). The maximum duration of administration for QL1706 is 24 months.

Timeline

• Start date: 2026-01-28
• Primary completion: 2028-06-30
• Completion: 2028-12-15
• First posted: 2025-12-01
• Last updated: 2026-03-30

Locations

14 sites across 1 country: China