RecruitingPhase 2NCT06686030

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


Sponsor

Akeso

Enrollment

150 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • Signs the written informed consent form.
  • Female participants who are at least 18 years of age on the day of signing informed consent with.
  • ECOG of 0 or 1.
  • Life expectancy ≥3 months.
  • 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:
  • If breast cancer susceptibility gene (BRCA) positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi).
  • Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified.
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team.
  • Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
  • Has adequate organ function.
  • 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 Criteria22

  • Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc.
  • Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
  • Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
  • Subjects with other active malignancies within 3 years prior to randomization.
  • Received systemic anti-tumor therapy within 2 weeks prior to randomization.
  • Any prior treatments targeting the mechanism of tumor immunity.
  • Major surgical , open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
  • Active or potentially recurrent autoimmune disease.
  • 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.
  • Receiving live vaccines within 4 weeks prior to randomization.
  • Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Known history of interstitial lung disease or non-infectious pneumonitis.
  • Serious infections requiring hospitalization.
  • Presence of active infection requiring systemic therapy.
  • Subjects with active hepatitis B and active viral hepatitis C.
  • Active or documented inflammatory bowel diseases, active diverticulitis.
  • Subjects with clinically significant cardio-cerebrovascular disease.
  • Unresolved toxicities from prior anticancer therapy.
  • History of severe hypersensitivity reactions to other mAbs.
  • Pregnant or lactating women.
  • Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

Interventions

DRUGAK112 low dose

10mg/kg, Q3W, ivgtt

DRUGChemotherapy

ivgtt

DRUGOlaparib

bid, oral

DRUGAK112 high dose

20mg/kg, Q3W, ivgtt


Locations(1)

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, China

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NCT06686030


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