Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer

February 10, 2026 updated by: Xiaoxiang Chen, Jiangsu Cancer Institute & Hospital

A Prospective, Open-label, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer

This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status:

Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + paclitaxel (175 mg/m², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)/cisplatin (75 mg/m², Q3W, D1). Planned enrollment: 30 patients.

Cohort 2: ECOG PS 2, BRCA1/2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg/m², Q3W, D1). Planned enrollment: 20 patients.

Neoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR/PR/SD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants voluntarily join this study, sign the informed consent form, and strictly comply with the protocol requirements;
  • Female patients aged between 18 and 75 years;
  • Patients who have undergone open surgery, laparoscopic surgery, or core needle aspiration biopsy, and have been histopathologically confirmed as having epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma), peritoneal cancer, or fallopian tube cancer, FIGO 2018 Stage III-IV;
  • Meet the indications for neoadjuvant chemotherapy in ovarian cancer: ① Preoperative assessment by gynecologic oncologists (with multidisciplinary consultation when necessary) indicates low likelihood of achieving R0 resection with primary debulking surgery; ② Physical condition unable to tolerate PDS, unsuitable for immediate surgery (e.g., high perioperative risk, advanced age, medical comorbidities, etc.); ③ No prior systemic anti-tumor treatment for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy); Note: Lymph node dissection or biopsy performed for clinical staging purposes after obtaining histopathology via needle biopsy, laparoscopic exploration, or other methods is permitted;
  • Accept BRCA1/2 genetic mutation or HRD testing;
  • Presence of at least one measurable lesion according to RECIST 1.1 criteria;
  • Expected survival time ≥12 weeks;
  • ECOG score 0-1 (for Cohort 1), ECOG score 2 (for Cohort 2);
  • Adequate organ function, including:

Bone marrow function: Absolute neutrophil count ≥1,500/μL; Platelets ≥100,000/μL; Hemoglobin ≥10 g/dL Hepatic function: Total bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin ≤1.0× ULN; AST and ALT ≤2.5× ULN; Must be ≤5× ULN when liver metastases are present Renal function: Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula);

  • Participants of childbearing potential must use appropriate contraceptive methods during the study period and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating participants.

Exclusion Criteria:

  • Non-epithelial origin ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors); ovarian tumors of low malignant potential (e.g., borderline tumors);
  • Concurrent use of other cancer neoadjuvant therapies during this study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other experimental therapies;
  • Hypersensitivity to the active or inactive ingredients of the investigational drug or drugs with similar structure to the investigational drug;
  • Inability to swallow oral medications and any gastrointestinal disorders that may interfere with the absorption and metabolism of study drugs (for Cohort 2);
  • Prior treatment with known or suspected poly (ADP-ribose) polymerase (PARP) inhibitors (for Cohort 2);
  • Presence of symptomatic or uncontrolled brain metastases requiring concurrent treatment;
  • Active or potentially recurrent autoimmune disease; exceptions include: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism caused by autoimmune thyroiditis requiring only stable dose hormone replacement therapy; Type 1 diabetes requiring only stable dose insulin replacement therapy;
  • Major surgery within 3 weeks before study initiation, or incomplete recovery from surgery;
  • History of organ transplantation, autologous/allogeneic stem cell transplantation;
  • Known or self-reported human immunodeficiency virus (HIV) infection;
  • HBV-DNA positive, HCV-DNA positive (copy number >10³);
  • Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.), immune cell therapy, or any other treatments targeting tumor immune mechanisms;
  • Live vaccine administered within 4 weeks before first dose, or planned live vaccine administration during the study period;
  • History of other malignancies within the past 3 years, except for cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ;
  • Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
  • Patients who received platelet or red blood cell transfusions within 4 weeks before initiation of study drug treatment;
  • Pregnant, lactating, or patients planning to become pregnant during study treatment;
  • Patients deemed unsuitable for participation in this study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1：QL1706+paclitaxel +carboplatin /cisplatin
Cohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + paclitaxel (175 mg/m², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)/cisplatin (75 mg/m², Q3W, D1). Planned enrollment: 30 patients.
Drug: Iparomlimab and Tuvonralimab (QL1706)Injection
5 mg/kg, Q3W, D1
Other Names:
  • QL1706
Drug: paclitaxel
175 mg/m², Q3W, D1
Drug: carboplatin
AUC 5-6, Q3W, D1
Drug: Cisplatin
75 mg/m², Q3W, D1
Drug: Cisplatin
intraperitoneal perfusion, 75 mg/m², Q3W, D1
Experimental: Cohort 2：QL1706+olaparib+intraperitoneal perfusion
Cohort 2: ECOG PS 2, BRCA1/2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg/m², Q3W, D1). Planned enrollment: 20 patients.
Drug: Iparomlimab and Tuvonralimab (QL1706)Injection
5 mg/kg, Q3W, D1
Other Names:
  • QL1706
Drug: Cisplatin
75 mg/m², Q3W, D1
Drug: Cisplatin
intraperitoneal perfusion, 75 mg/m², Q3W, D1
Drug: Olaparib
300 mg, for 2-3 cycles, bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: From enrollment to the end of treatment at 9 weeks
Incidence and severity of AEs and TEAEs, vital signs, and clinically significant abnormal laboratory findings during the study period
From enrollment to the end of treatment at 9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ORR
Time Frame: From enrollment to the end of treatment at 9 weeks
From enrollment to the end of treatment at 9 weeks
R0 Resection Rate
Time Frame: Periprocedural
Periprocedural
DCR
Time Frame: From enrollment to the end of treatment at 9 weeks
From enrollment to the end of treatment at 9 weeks
12month-OS
Time Frame: From enrollment to the end of treatment at 12 month
From enrollment to the end of treatment at 12 month
24month-OS
Time Frame: From enrollment to the end of treatment at 24 month
From enrollment to the end of treatment at 24 month
OS
Time Frame: From enrollment to the end of treatment at 36 month
From enrollment to the end of treatment at 36 month
12month-PFS
Time Frame: From enrollment to the end of treatment at 12 month
From enrollment to the end of treatment at 12 month
PFS
Time Frame: From enrollment to the end of treatment at 24 month
From enrollment to the end of treatment at 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancers

Clinical Trials on Iparomlimab and Tuvonralimab (QL1706)Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe