Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: SHR-A1811: Dosage Form: Injection (lyophilized powder)
Dosage Frequency/regimen: 4.8 mg/kg IV Q3W
Mode of Administration: Intravenous administration IV infusion
Control Intervention1
dosage regimen: 40 mg/m2 IV Q4W)
Control Intervention2: Paclitaxel: Dose form: Injection
dosage regimen: 80 mg/m2 IV on D1, D8, D15, and D22 of each cycle
4 week as one cycle
Control Intervention3: Topotecan: Dose form: Injection
dosage regimen: 4 mg/m2 IV on D1, D8, and D15 of each cycle, with 4 weeks as one treatment cycle
Control Intervention4: Gemcitabine: Dose form: Injection
dosage regimen: 1,000 mg/m2 IV on D1 and D8 of each cycle, with 3 weeks as one treatment cycle
Sponsors
Glenmark Specialty SA
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants aged 18 to 75 years inclusive, age calculated on the date of signing the Informed Consent Form ICF, who have provided voluntary written informed consent. 2. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 3. Documented platinum resistant recurrence after prior platinum based therapy, defined as progressive disease during platinum treatment or within less than 183 days after the last dose of platinum based therapy. 4. HER2 expression of IHC 1 plus, 2 plus, or 3 plus. 5. At least one measurable lesion as defined by RECIST version 1.1. Lesions previously treated with local therapy may be selected as target lesions if there is clear evidence of significant progression after completion of local treatment. 6. ECOG Performance Status score of 0 or 1. 7. Expected survival of at least 12 weeks. 8. Adequate organ function, including bone marrow, liver, and kidney function, as defined in the study protocol. 9. For female participants of childbearing potential must have a negative pregnancy test during the screening period. Participants must agree to use effective contraception and must not donate eggs during study participation.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed sarcomatous histologic subtype, or mixed tumors containing sarcomatous components. 2. Untreated or active CNS metastases, or a history of or current meningeal metastases. 3. Prior treatment with topoisomerase I inhibitors (including but not limited to irinotecan, topotecan), or treatment with antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor payload, such as Enhertu (DS-8201a) and U3-1402. 4. Receipt of systemic anti-tumor therapy within 4 weeks prior to the initiation of study treatment. For prior treatment with small molecule targeted therapies, the interval between end of treatment and the first dose of study treatment must be at least 5 half-lives of the drug or 7 days. 5. Presence of symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion, or ascites. 6. Receipt of palliative radiotherapy within 7 days prior to the first dose of study treatment. 7. History of or concurrent other malignancies, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid cancer, or other malignancies that have been adequately treated and cured for greater than and equall to 3 years prior to randomization and for which there is documented evidence of no recurrence or metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression Free Survival (PFS) assessed by the Independent Review Committee (IRC) based on RECIST v1.1. 2. Overall Survival (OS)Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| IRC-assessed ORR, DoR, and DCR per RECIST v1.1Timepoint: ;Investigator-assessed PFS, ORR, DoR, and DCR per RECIST v1.1Timepoint: ;CA-125 RR assessed based on GCIG CA-125 criteriaTimepoint: ;RR assessed based on CA-125 RR and IRC ORRTimepoint: ;AEs and SAEs, including type, incidence, severity (graded according to the NCI-CTCAE v6.0), and relation to study drugTimepoint: ;Laboratory parameter abnormalities, including type, incidence, and grading (per NCI-CTCAE v6.0)Timepoint: ;Vital signs, electrocardiogram (ECG), and ECOG PS scoreTimepoint: ;Serum concentrations of the toxin-conjugated antibody (SHR-A1811) and the free toxin SHR169265Timepoint: ;Presence of anti-SHR-A1811 antibodies (ADAs) and neutralizing antibodies (NAbs)Timepoint: | — |
Countries
Australia, India, Republic of Korea
Contacts
Public ContactAmol Pendse
Glenmark Specialty SA
Outcome results
None listed