Ovarian cancer
Conditions
Interventions
Dose Escalation:Three dose cohorts (3.33, 8.33, and 16.67 µg/kg), administered intraperitoneally BIW in a 2-week treatment cycle, after DLT observation, the investigator will assess whether to enter t
Dose Expansion:After determination of MTD or MAD and the expected effective Dose Level, this part with expansion cohorts will commence to further evaluate the RP2D
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, age >=18 years old, =4 cycles of platinum-based therapy, followed by confirmed disease recurrence or progression 28 days to 6 months after the last platinum-containing regimen. At least one subsequent systemic therapy for recurrence/progression following platinum resistance, with =3 months. 7. Adequate major organ function within 14 days prior to treatment : Hematology (without transfusion or hematopoietic growth factor support within 14 days): NEUT >=1.5×10?/L, PLT >=100×10?/L, Hb >=80 g/L. Liver function: ALT 50 mL/min. Coagulation function: APTT <=1.5 × ULN, INR <=1.5 × ULN. 8. At least one measurable lesion per RECIST v1.1 criteria. 9. Female subjects of childbearing potential must agree to use effective contraceptive methods from signing ICF until at least 6 months after the last dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1. Participation in another investigational drug trial within 4 weeks before enrollment. 2. Non-epithelial ovarian cancer. 3. Prior antineoplastic therapy (including chemotherapy, radiotherapy, targeted therapy, hormonal therapy, biologic therapy, immunotherapy, herbal medicine for antineoplastic purposes, or other investigational agents) within 28 days or 5 half-lives (whichever shorter) prior to first dose. 4. Prior radiotherapy within 4 weeks prior to the first dose (including radiotherapy to >25% of bone marrow), or palliative localized radiotherapy to bone metastases within 2 weeks. 5. Major surgery within 4 weeks prior to the first dose without complete recovery, or elective surgery planned during the trial. 6. Other malignancies within the past 5 years (except stable breast cancer; except for adequately treated non-melanoma skin cancer or other solid tumors with no evidence of disease for >5 years). 7. Any toxicity from prior therapy that has not recovered to baseline or to ULN (enrollment allowed if reduced to normal post-antiviral), Anti-HCV positive with HCV RNA positive, Tp-Ab positive. 10. Active infection requiring systemic anti-infective therapy (per investigator). 11. Pregnant or breastfeeding. 12. Known history of drug/alcohol/substance abuse, definite prior history of neurological or psychiatric disorders. 13. Presence of any active autoimmune disease, history of autoimmune disease or acquired immunodeficiency syndrome. 14. Corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 4 weeks prior to study drug, or requiring long-term systemic steroids during study (topical steroids allowed). 15. Uncontrolled or significant cardiovascular disease, including severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction within 6 months prior to the first dose. 16. Poorly controlled hypertension despite antihypertensive therapy (i.e., SBP >=150 mmHg and/or DBP >=100 mmHg). 17. Uncontrolled diabetes (defined as HbA1c >=8%, or 7% = HbA1c = Grade 2), or severe gastrointestinal obstruction requiring intervention. 18. Pulmonary disease defined as >= Grade 3 per NCI-CTCAE v6.0, including dyspnea at rest, requirement for continuous oxygen therapy, or history of ILD. 19. Known allergy to the investigational product or its major excipients, or kanamycin. 20. History of thromboembolism, cerebral infarction, hemorrhagic disorders, or evidence of bleeding tendency within 6 months prior to the first dose. 21. Any other concurrent severe and/or uncontrolled medical condition that, in the investigator's judgment, renders the patient unsuitable for participation. 22. Female patients of childbearing potential unwilling to use effective contraception during the trial and for 6 months post-treatment. Pregnancy test required for patients with am
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (Dose Escalation);Recommended Phase II Dose (RP2D) (Dose Expansion); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK characteristics (Dose Escalation);Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DoR);Progression-Free Survival (PFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactRutie Yin
West China Second University Hospital, Sichuan University
Outcome results
None listed