A Phase II Study to Evaluate the Efficacy and Safety of QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, single-arm, multicenter Phase II study evaluating the efficacy and safety of QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who progressed after prior anti-PD-1/L1 therapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age ≥18 years and ≤70 years.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Recurrent or metastatic endometrial carcinoma, confirmed by pathology or imaging.

• At least one measurable tumor lesion according to RECIST v1.1 criteria.

• Patients must have received prior anti-PD-1/L1 monoclonal antibody (mAb) therapy with a progression-free survival (PFS) of ≥6 months; however, the last dose of anti-PD-1/L1 mAb must have been administered at least 5 half-lives before the initiation of the current treatment.

• Patients who have received prior anti-angiogenic therapy are eligible, provided there is a washout period of at least 5 half-lives before re-administration.

• Patients who have failed ≤2 lines of prior systemic therapy are eligible (endocrine therapy is not counted as a line of treatment).

• All other anti-tumor therapies must be discontinued at least 4 weeks before treatment initiation. Patients taking hormonal medications require a 30-day washout period.

• Laboratory tests during the screening period must demonstrate adequate organ function.

⁃ Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use an acceptable and highly effective contraceptive method since screening and must agree to continue such precautions until 6 months after the last dose of the study drug; periodic abstinence and the rhythm method are not acceptable forms of contraception.

⁃ Voluntarily sign the informed consent form, understand the nature, purpose, and procedures of the trial, and willingly comply with the trial requirements.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
Wen X Liu, Doctor
wenxin1973@163.com
+86 13702169191
Backup
Lu Sun
sun_sl2006@126.com
+86 18722068811
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 30
Treatments
Experimental: QL1706 Combination Therapy
QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Carcinoma
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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