NCT07407452

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Dec 2028

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 3, 2026

Last Update Submit

February 10, 2026

Conditions

Ovarian Cancers

Keywords

ovarian cancerICIsNeoadjuvant therapyQL1706olaparib

Outcome Measures

Primary Outcomes (1)

  • AEs

    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 Outcomes (8)

  • ORR

    From enrollment to the end of treatment at 9 weeks

  • R0 Resection Rate

    Periprocedural

  • DCR

    From enrollment to the end of treatment at 9 weeks

  • 12month-OS

    From enrollment to the end of treatment at 12 month

  • 24month-OS

    From enrollment to the end of treatment at 24 month

  • +3 more secondary outcomes

Study Arms (2)

Cohort 1：QL1706+paclitaxel +carboplatin /cisplatin

EXPERIMENTAL

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)InjectionDrug: paclitaxelDrug: carboplatinDrug: Cisplatin

Cohort 2：QL1706+olaparib+intraperitoneal perfusion

EXPERIMENTAL

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)InjectionDrug: OlaparibDrug: Cisplatin

Interventions

Iparomlimab and Tuvonralimab (QL1706)InjectionDRUG

5 mg/kg, Q3W, D1

Also known as: QL1706
Cohort 1：QL1706+paclitaxel +carboplatin /cisplatinCohort 2：QL1706+olaparib+intraperitoneal perfusion
paclitaxelDRUG

175 mg/m², Q3W, D1

Cohort 1：QL1706+paclitaxel +carboplatin /cisplatin
carboplatinDRUG

AUC 5-6, Q3W, D1

Cohort 1：QL1706+paclitaxel +carboplatin /cisplatin
CisplatinDRUG

75 mg/m², Q3W, D1

Cohort 1：QL1706+paclitaxel +carboplatin /cisplatin
OlaparibDRUG

300 mg, for 2-3 cycles, bid

Cohort 2：QL1706+olaparib+intraperitoneal perfusion

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

PaclitaxelCarboplatinCisplatinolaparib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Xiao Xiang Chen

CONTACT

+86-13851647229cxxxxcyd@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Director

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 12, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

CN(1)