QL1706 Combined with Chemotherapy in the Treatment of Recurrent or Metastatic Endometrial Cancer

NCT06751277 | Not Yet Recruiting Phase 2

• 1 other identifier: QLMA-EdC-IIT-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

the investigators planned to evaluate the efficacy and safety of QL1706 in combination with chemotherapy as first-line systemic therapy in approximately 26 patients with newly diagnosed recurrent or metastatic endometrial cancer in a single-arm, open-label, multicenter study. The main questions it aims to answer are: Evaluate the efficacy and safety of QL1706 plus chemotherapy as first-line systemic therapy for recurrent or metastatic disease. According to the treatment regimen, a total of 26 subjects were enrolled. Eligible subjects received QL1706 (5mg/kg, Q3W, d1) plus carboplatin (AUC=5, Q3W, d1) plus paclitaxel (175mg/m2, Q3W, d1) for six to eight cycles at the investigator's discretion, followed by QL1706 (5mg/kg, Q3W, d1). d1) until disease progression, development of unacceptable toxicity, lack of benefit as judged by the investigator, withdrawal of consent, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.

Conditions

Recurrent or Metastatic Endometrial Cancer

Keywords

immunotherapy; anti-PD-1 antibody; anti-CTLA-4 antibody.; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  The best overall response (BOR) was defined as the proportion of subjects who achieved a confirmed CR or PR (according to RECIST v1.1).

  up to 5 months

Secondary Outcomes (3)

• PFS

  up to 13months

• DoR

  up to 5 months

• OS

  up to 45 months

Study Arms (1)

Experimental

EXPERIMENTAL

QL1706（iparomlimab and tuvonralimab a bifunctional MabPair® product of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies） plus carboplatin and paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706 until disease progression, development of unacceptable toxicity, lack of benefit as judged by the investigator, withdrawal of consent, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.

Drug: QL1706 plus carboplatin plus paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706

Interventions

QL1706 plus carboplatin plus paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706 DRUG

QL1706 plus carboplatin plus paclitaxel for six to eight cycles at the investigator's discretion, followed by QL1706

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign a written ICF.
• The age at enrollment was ≥18 years old, ≤75 years old, female.
• Eastern Cooperative Oncology (ECOG) performance status of 0 or 1.
• Expected survival time ≥3 months.
• Histologically confirmed stage III/IV or recurrent endometrial cancer, who have not received first-line systemic anticancer therapy, and are not suitable for other treatments other than systemic therapy (e.g., unable or unable to tolerate surgery, unsuitable for radiotherapy, etc.).
• Presence of measurable lesions as required by: a) at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1); Lymph nodes with the long diameter of non-lymph node lesions ≥10mm or the short diameter of lymph node lesions ≥15mm can be measured repeatedly. b) Lesions receiving external beam radiation therapy (EBRT) or locoregional therapy (such as radiofrequency ablation) must show subsequent evidence of substantial size increase to be considered target lesions.
• Good function of major organs:
• Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first dose of medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test should be performed, and the result is negative). If a female subject of childbearing potential has sex with an unsterilized male partner, the subject must be using an acceptable method of contraception from the time of screening and must agree to continue using contraception for 120 days after the last dose of study drug. Discontinuation of contraception after this time point should be discussed with the investigator.
• Participants were willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.

You may not qualify if:

• Participated in treatment with the investigational drug or used the investigational device within 4 weeks before the first dose of QL1706.
• Enroll in another clinical study at the same time, unless it is the follow-up period of an observational (nonintervention) clinical study or an intervention study (defined as the first dose of the study drug is more than 4 weeks after the last dose of the previous clinical study or more than 5 half-lives of the study drug, whichever is the longest).
• Carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma.
• Active autoimmune disease requiring systemic treatment within 2 years before the initiation of study treatment, or autoimmune disease with potential recurrence or planned treatment as judged by the investigator; Exceptions include skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); Hypothyroidism due to autoimmune thyroiditis requires only stable doses of hormone replacement therapy. Well-controlled type I diabetes; Subjects who have had complete remission of childhood asthma without any intervention in adulthood; The investigator judged that the disease would not recur in the absence of an external trigger.
• Inflammatory bowel disease associated with active disease or requiring clinical management (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
• History of a known positive test for human immunodeficiency virus or a known positive test for acquired immunodeficiency syndrome.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Known presence or history of interstitial lung disease.
• History of gastrointestinal perforation and/or fistula within 6 months before enrollment.
• The subject had a necrotizing lesion on examination within 4 weeks before enrollment and was judged by the investigator to be at risk for major bleeding.
• Serious infection within 4 weeks before the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
• Known active pulmonary tuberculosis (TB). Subjects suspected to have active TB were examined by chest X-ray, sputum, and excluded by clinical signs and symptoms.
• Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \> 1000IU/mL, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HbsAg) carriers, treated patients with stable hepatitis B (HBV DNA\<1000IU/mL), and patients with cured hepatitis C were eligible. For subjects who were positive for HCV Ab, they were eligible to participate in the study only if they had a negative HCV RNA test result.
• Known presence of leptomeningeal metastases, spinal cord compression, leptomeningeal disease, or active brain metastases. However, subjects with measurable lesions outside the central nervous system were allowed if they: 1) had not been previously treated and were currently asymptomatic (e.g., absence of neurological dysfunction, epilepsy, or other symptoms and signs typical of central nervous system metastases; No need for corticosteroids). 2) treatment-naive asymptomatic patients who have been radiographically stable for at least 4 weeks (e.g., no new or expanding brain metastases) before the initiation of study treatment and who have stopped systemic glucocorticoids and anticonvulsants for at least 2 weeks.
• Subjects with pleural, pericardial, or ascites that could not be stably controlled by repeated drainage or other methods, as judged by the investigator.

Sponsors & Collaborators

• xiang yang: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Recurrence; Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peking Union Medical College Hospital

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 27, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)