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Not yet recruitingNCT07454018Updated Mar 6, 2026

Iparomlimab/Tuvonralimab + Standard Chemotherapy and Olaparib in Platinum-Sensitive Recurrent Ovarian Cancer

A Phase 2 interventional study of Iparomlimab/Tuvonralimab in Recurrent Ovarian Cancer and Platinum-sensitive Ovarian Cancer, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This is a prospective, open-label, single-arm, multicenter exploratory clinical study designed to evaluate the efficacy and safety of iparomlimab/tuvonralimab (QL1706), a bispecific antibody targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), in combination with standard platinum-based chemotherapy followed by olaparib in patients with platinum-sensitive recurrent epithelial ovarian cancer.

Eligible participants are women aged 18-75 years with histologically or cytologically confirmed non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma) who experience first or second recurrence at least 6 months after the last platinum-containing chemotherapy, have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and are deemed not suitable for surgery by the investigator.

The study consists of a screening period (up to 28 days), a treatment period, and a follow-up period. Treatment is administered in 3-week cycles and continues until disease progression, unacceptable toxicity, withdrawal of consent, loss of clinical benefit per investigator judgment, completion of 2 years of iparomlimab/tuvonralimab (QL1706), or other protocol-defined reasons. Safety assessments are performed regularly during treatment; a safety follow-up visit is conducted 30 (±7) days after the last dose, and survival follow-up is performed every 2 months thereafter. The primary objective is to explore the antitumor efficacy of the regimen in platinum-sensitive recurrent epithelial ovarian cancer, and the secondary objective is to characterize the safety profile of the combination strategy.

02

Conditions studied

  • Recurrent Ovarian Cancer
  • Platinum-sensitive Ovarian Cancer

Keywords

  • Iparomlimab
  • Tuvonralimab
  • Epithelial ovarian cancer
  • Maintenance therapy
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 45 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female participants aged 18 to 75 years. Voluntarily provide written informed consent and able to comply with protocol requirements.
  2. Histologically and/or cytologically confirmed recurrent non-mucinous epithelial ovarian cancer (including serous carcinoma, clear cell carcinoma, endometrioid carcinoma, and carcinosarcoma).
  3. First or second recurrence after standard platinum-containing chemotherapy, with recurrence diagnosed ≥ 6 months after the last dose of platinum-containing chemotherapy (platinum-sensitive recurrence).
  4. Not suitable for surgery as assessed by the investigator.
  5. At least one measurable lesion per RECIST v1.1.
  6. ECOG performance status 0-1.
  7. If no prior BRCA1/2 mutation test result is available, willing to provide tumor tissue and/or peripheral blood for confirmation of BRCA status (archival or fresh tumor tissue preferred; if re-biopsy poses safety risk, may be discussed with medical monitor).
  8. Prior exposure to PARP inhibitor(s) other than olaparib is allowed only if the prior PARPi exposure after first-line therapy was >18 months for BRCA-mutated participants or >12 months for BRCA wild-type participants, and recurrence occurred ≥12 months after the last PARPi dose.
  9. Estimated life expectancy ≥ 3 months.
  10. Adequate organ function: ANC ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L; serum albumin ≥30 g/L; TSH ≤1×ULN (if abnormal, FT3/FT4 within normal range); total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN (≤5×ULN if liver metastases); ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN; INR ≤1.5 (if not on anticoagulation).
  11. Women of childbearing potential must have a negative serum/urine pregnancy test within 7 days prior to first dose, must not be breastfeeding, and must use medically accepted contraception during study treatment and for 3 months after the end of study treatment.

Exclusion criteria

Exclusion Criteria:

  1. Any active autoimmune disease or history of autoimmune disease.
  2. Mucinous ovarian cancer, sex cord-stromal tumors, or other non-eligible histologic types.
  3. Uncontrolled pleural effusion, pericardial effusion, or ascites that cannot be stabilized despite repeated drainage or other interventions per investigator judgment.
  4. Other active malignancy within 2 years prior to first dose.
  5. Central nervous system metastases or carcinomatous meningitis.
  6. Palliative radiotherapy or immunomodulatory agents (e.g., thymosin, interferon, IL-2) or antitumor Chinese patent medicines within 2 weeks prior to first dose; hormonal therapy within 1 week prior to first dose.
  7. Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (prednisone >10 mg/day or equivalent) within 2 weeks prior to enrollment.
  8. Prior immuno-oncology therapies targeting tumor immunity (e.g., PD-1/PD-L1/CTLA-4 inhibitors, immune checkpoint agonists such as ICOS/CD40/CD137/GITR/OX40 antibodies, or immune cell therapy).
  9. Prior treatment with olaparib.
  10. Concomitant use of strong/moderate CYP3A inhibitors (washout 2 weeks) or strong/moderate CYP3A inducers (washout 5 weeks for enzalutamide/phenobarbital; 3 weeks for others).
  11. Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to first dose (except secondary cytoreductive surgery), or planned major elective surgery during the study.
  12. Live vaccine within 4 weeks prior to first dose or planned live vaccination during the study.
  13. Known primary or secondary immunodeficiency, including HIV antibody positive. Untreated chronic hepatitis B or HBV carrier with HBV DNA >1000 IU/mL; active hepatitis C.
  14. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  15. History of interstitial lung disease or non-infectious pneumonitis.
  16. Serious infection within 4 weeks prior to first dose (e.g., sepsis, severe pneumonia, or infections requiring hospitalization).
  17. Active or clinically significant inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea requiring treatment).
  18. Severe cardiovascular or cerebrovascular disease/history.
  19. Peripheral neuropathy ≥ Grade 2 per NCI CTCAE v5.0.
  20. History of severe hypersensitivity reaction to other monoclonal antibodies. Pregnant or breastfeeding.
  21. Known allergy to any component of QL1706, olaparib, carboplatin, or paclitaxel formulations.
  22. Participation in another investigational drug/device study within 4 weeks prior to first dose.
  23. Any condition that, in the investigator's opinion, would increase risk with study treatment or interfere with study assessments or interpretation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Iparomlimab/Tuvonralimab + Carboplatin + Nab-paclitaxel → Olaparib

    Participants receive iparomlimab/tuvonralimab in combination with carboplatin and nab-paclitaxel administered in 3-week cycles during the induction phase. After completion of induction therapy, participants receive oral olaparib as maintenance therapy according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, completion of 2 years of iparomlimab/tuvonralimab treatment, or other protocol-defined discontinuation criteria.

    Drug: Iparomlimab/Tuvonralimab

Interventions

  • DrugIparomlimab/Tuvonralimab

    Iparomlimab/Tuvonralimab administered intravenously in 3-week cycles per protocol

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time from first dose to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Time frame: Up to 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07454018
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Jinhua Zhou (Director, Department of Obstetrics and Gynecology, The First Affiliated Hospital of Soochow University) — Principal investigator
First posted
Mar 6, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Mar 6, 2026

Study contacts

Jinhua Zhou, PHD
Contact
jsjhzh@126.com
0512-67972032
SJ Wu
Contact
0512-67972861

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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