Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

An Exploratory, Multi-cohort Phase II Study of Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer (NCT06686030) is a Phase 2 interventional studying Platinum-sensitive Ovarian Cancer, sponsored by Akeso. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Platinum-sensitive Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Platinum-sensitive Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signs the written willing to sign a consent form form. 2. Female participants who are at least 18 years of age on the day of signing willing to sign a consent form with. 3. ECOG of 0 or 1. 4. Life expectancy ≥3 months. 5. Histologically documented epithelial and non-mucinous PSOC. PSOC was defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy. Note: 1. If breast cancer susceptibility gene (BRCA) positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi). 2. Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. 7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. 8. Has your organs (liver, kidneys, etc.) are working well enough based on blood tests. 9. All subjects of reproductive potential must agree to use an effective method of contraception, during and for 6 months after the last dose of study treatment. Who Should NOT Join This Trial: 1. Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc. 2. Presence of central nervous system (CNS) metastases or carcinomatous meningitis. 3. Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage. 4. Subjects with other active malignancies within 3 years prior to randomization. 5. Received systemic anti-tumor therapy within 2 weeks prior to randomization. 6. Any prior treatments targeting the mechanism of tumor immunity. 7. Major surgical , open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Signs the written informed consent form. 2. Female participants who are at least 18 years of age on the day of signing informed consent with. 3. ECOG of 0 or 1. 4. Life expectancy ≥3 months. 5. Histologically documented epithelial and non-mucinous PSOC. PSOC was defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy. Note: 1. If breast cancer susceptibility gene (BRCA) positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi). 2. Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. 7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. 8. Has adequate organ function. 9. All subjects of reproductive potential must agree to use an effective method of contraception, during and for 6 months after the last dose of study treatment. Exclusion Criteria: 1. Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc. 2. Presence of central nervous system (CNS) metastases or carcinomatous meningitis. 3. Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage. 4. Subjects with other active malignancies within 3 years prior to randomization. 5. Received systemic anti-tumor therapy within 2 weeks prior to randomization. 6. Any prior treatments targeting the mechanism of tumor immunity. 7. Major surgical , open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study. 8. Active or potentially recurrent autoimmune disease. 9. Subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization. 10. Receiving live vaccines within 4 weeks prior to randomization. 11. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies. 12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 13. Known history of interstitial lung disease or non-infectious pneumonitis. 14. Serious infections requiring hospitalization. 15. Presence of active infection requiring systemic therapy. 16. Subjects with active hepatitis B and active viral hepatitis C. 17. Active or documented inflammatory bowel diseases, active diverticulitis. 18. Subjects with clinically significant cardio-cerebrovascular disease. 19. Unresolved toxicities from prior anticancer therapy. 20. History of severe hypersensitivity reactions to other mAbs. 21. Pregnant or lactating women. 22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug. 23. Exclusion Criteria for combination therapy-Related: For cohort 1: Known contraindications or allergy to paclitaxel or carboplatin. For Cohorts 1-10A, Cohort 1-20A, and Cohort 2: Known contraindications or allergy to Olaparib. 24. Exclusion Criteria for AK112-Related: Known contraindications or allergy to any component of VEGF mABs or any medical conditions that affect the safety of AK112.

Treatments Being Tested

DRUG

AK112 low dose

10mg/kg, Q3W, ivgtt

DRUG

Chemotherapy

ivgtt

DRUG

Olaparib

bid, oral

DRUG

AK112 high dose

20mg/kg, Q3W, ivgtt

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06686030), the sponsor (Akeso), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06686030 clinical trial studying?

An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06686030?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06686030?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06686030. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06686030. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.