QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer

NCT06917092 | Recruiting Phase 2 DMC

• 1 other identifier: E20250167
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Adenocarcinoma; Endometrial Cancer

Keywords

Immunotherapy-Pretreated; Recurrent or Metastatic Endometrial Carcinoma; Immune Checkpoint Inhibitors; QL1706

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) - Investigator assessment

  the objective response rate (ORR) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.

  Up to 5 years

Secondary Outcomes (4)

• Progression-Free Survival (PFS) - investigator assessment

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Duration of response (DOR) - Investigator assessment

  Up to 5 years

• Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

  Up to 5 years

Study Arms (1)

QL1706 Combination Therapy

EXPERIMENTAL

QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Carcinoma

Drug: QL1706 combined with chemotherapy ± Bevacizumab

Interventions

QL1706 combined with chemotherapy ± Bevacizumab DRUG

* Drug: QL1706: 5 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first. * Drug: Chemotherapy: physician's choice chemotherapy for 3-6 cycles. * Drug: Bevacizumab (optional): 15 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first.

QL1706 Combination Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Previous treatment with PD-1/CTLA-4 dual-target immunotherapy, immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or immune cell therapy.
• \. Discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity. 3. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring bronchodilator treatment is excluded).
• \. Current use of immunosuppressants or systemic corticosteroids for immunosuppression (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
• \. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• \. History of severe allergic reactions to monoclonal antibodies. 8. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
• \. History or current presence of central nervous system (CNS) metastases. Baseline imaging to confirm the absence of brain metastases is not mandatory. Patients with unknown CNS status but clinical signs suggestive of CNS metastases must be excluded via CT/MRI.
• \. History of other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ; patients with other prior malignancies must have been disease-free for at least 3 years).
• \. Uncontrolled hypertension despite antihypertensive therapy (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg); hypertensive crisis or hypertensive encephalopathy in the past.
• \. History of unstable angina, myocardial infarction (MI), chronic heart failure (CHF), clinically significant arrhythmias requiring treatment (except stable atrial fibrillation), or left ventricular ejection fraction \<50% within 6 months before the first dose.
• \. Current thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin or low molecular weight heparin is permitted).
• \. Arterial/venous thrombotic events within 6 months before enrollment (e.g., cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism).
• \. Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).
• \. Major surgery within 4 weeks before study treatment (excluding diagnostic procedures) or anticipated major surgery during the study.
• \. Prior radiotherapy (except palliative bone radiotherapy), chemotherapy, or surgery (excluding biopsy) within 4 weeks before the first study dose; last antibody dose \<4 weeks before study treatment; molecular targeted therapy (including other investigational oral targeted agents) \<5 half-lives before study treatment; or unresolved toxicities (\>CTCAE grade 1, except alopecia) from prior therapy.
• \. Active infection, unexplained fever ≥38.5°C within 7 days before treatment, or baseline white blood cell count \>15×10⁹/L.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wen X Liu, Doctor

CONTACT

+86 13702169191; wenxin1973@163.com

Lu Sun

CONTACT

+86 18722068811; sun_sl2006@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)