Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer

NCT07432594 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-I2M-C&T-B-065
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomized, controlled Phase II clinical study designed to evaluate the efficacy and safety of adding Aitua Combination Antibody (a PD-1/CTLA-4 bispecific antibody) to standard neoadjuvant chemotherapy for patients with advanced high-grade serous ovarian cancer. The study focuses on patients who are newly diagnosed with Stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer and are assessed as unable to achieve satisfactory tumor debulking (R0 resection) initially. Participants will be randomized in a 1:1 ratio into two groups: Experimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody. Control Group: Receives Nab-paclitaxel and Carboplatin alone. Both groups will receive 3 cycles of neoadjuvant treatment followed by Interval Debulking Surgery (IDS). The primary goal is to compare the R0 resection rate (complete removal of macroscopic tumor) between the two groups during surgery. Secondary goals include assessing pathological complete response (pCR), objective response rate, progression-free survival, and safety. The study also aims to explore how this combination therapy affects the tumor immune microenvironment.

Conditions

High-grade Serous Ovarian Cancer (HGSOC); Fallopian Tube Cancers; Primary Peritoneal Cancer

Keywords

Neoadjuvant Chemotherapy; Interval Debulking Surgery; PD-1/CTLA-4 Bispecific Antibody; Aitua Combination Antibody; Nab-paclitaxel; Carboplatin; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of R0 resection

  Defined as the percentage of participants achieving optimal debulking surgery with no macroscopic residual disease (R0) after neoadjuvant therapy. This is assessed by the surgeon at the time of interval debulking surgery (IDS).

  At the time of surgery, up to 12 weeks

Secondary Outcomes (5)

• Pathological complete response (pCR) rate

  At the time of surgery, up to 12 weeks

• Objective response rate (ORR)

  From baseline up to approximately 2 years

• Disease control rate (DCR)

  From baseline up to approximately 2 years

• Progression-free survival (PFS)

  From randomization up to approximately 2 years

• Incidence and severity of adverse events (AEs)

  Through 28 days after the last dose of study drug, up to approximately 2 years

Other Outcomes (1)

• Change in tumor immune microenvironment (TiME) characteristics

  At baseline, and at the time of surgery (up to 12 weeks)

Study Arms (2)

Nab-Paclitaxel + Carboplatin + Aitua Combo Ab

EXPERIMENTAL

Participants receive Nab-paclitaxel (260 mg/m\^2), Carboplatin (AUC 4-5), and Aitua Combination Antibody (5 mg/kg) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).

Drug: Aitua Combination Antibody; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Carboplatin (AUC 5); Procedure: Interval Debulking Surgery

Nab-Paclitaxel + Carboplatin

ACTIVE COMPARATOR

Participants receive Nab-paclitaxel (260 mg/m\^2) and Carboplatin (AUC 4-5) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).

Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Carboplatin (AUC 5); Procedure: Interval Debulking Surgery

Interventions

Aitua Combination Antibody DRUG

Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.

Also known as: PD-1/CTLA-4 Bispecific Antibody, QL1706

Nab-Paclitaxel + Carboplatin + Aitua Combo Ab

Albumin-Bound Paclitaxel /nab-Paclitaxel DRUG

Administered via intravenous infusion at a dose of 260 mg/m\^2 on Day 1 of each 3-week cycle.

Nab-Paclitaxel + Carboplatin; Nab-Paclitaxel + Carboplatin + Aitua Combo Ab

Carboplatin (AUC 5) DRUG

Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.

Nab-Paclitaxel + Carboplatin; Nab-Paclitaxel + Carboplatin + Aitua Combo Ab

Interval Debulking Surgery PROCEDURE

Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).

Nab-Paclitaxel + Carboplatin; Nab-Paclitaxel + Carboplatin + Aitua Combo Ab

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.
• International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
• Major organ function is basically normal.
• Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.

You may not qualify if:

• Pathological types other than high-grade serous carcinoma (HGSC).
• Prior receipt of any form of anti-tumor therapy.
• History of autoimmune disease or requiring immunosuppressive therapy.
• Known allergy to study drug components.
• Pregnant or lactating women.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Ning Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

8610-87787211; liningnci@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study; however, radiological assessments (for ORR/PFS) and pathological assessments (for pCR) will be performed by blinded independent reviewers who are unaware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This is a prospective, randomized, open-label, controlled study. Eligible participants are stratified by FIGO stage (IIIC vs. IV) and randomized in a 1:1 ratio to receive either the experimental regimen or the control regimen.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share