CTRI/2026/07/113491 [Registered on: 06/07/2026] Trial Registered Prospectively
Last Modified On:
06/07/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to assess efficacy and safety of SHR-A1811 in the treatment of patients with Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer after undergoing platinum compound cancer therapy.
Scientific Title of Study
An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
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
Comparator Agent
Liposomal doxorubicin
(Dose form: Injection; dosage regimen: 40 mg/m2 IV Q4W)
Comparator Agent
Paclitaxel
Dose form: Injection; dosage regimen: 80 mg/m2 IV on D1, D8, D15, and D22 of each cycle; 4 week as one cycle
Intervention
SHR-A1811
Dosage Form: Injection (lyophilized powder)
Dosage Frequency/regimen: 4.8 mg/kg IV Q3W
Mode of Administration: Intravenous administration IV infusion
Comparator Agent
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
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Female, aged 18 to 75 years (inclusive of 18 and 75 years; age calculated as on the date of ICF signing) and has 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 PD during platinum treatment or within lessthan 183 days after the last dose of platinum-based therapy)
4. HER2 expression of IHC 1+, 2+, or 3+
5. At least one measurable lesion as defined by RECIST v1.1. 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 PS score of 0 to 1.
7. Expected survival of greater than or equal to 12 weeks.
8. Adequate organ function (e.g., bone marrow, liver, kidney) as defined in the study protocol.
9. For female subjects of childbearing potential, a negative pregnancy test result must be confirmed during the screening period. Subjects must agree to use effective contraception and refrain from egg donation during the study participation.
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Progression Free Survival (PFS) assessed by the Independent Review Committee (IRC) based on RECIST v1.1.
2. Overall Survival (OS)
Secondary Outcome
Outcome
TimePoints
IRC-assessed ORR, DoR, and DCR per RECIST v1.1
Investigator-assessed PFS, ORR, DoR, and DCR per RECIST v1.1
CA-125 RR assessed based on GCIG CA-125 criteria
RR assessed based on CA-125 RR and IRC ORR
AEs and SAEs, including type, incidence, severity (graded according to the NCI-CTCAE v6.0), and relation to study drug
Laboratory parameter abnormalities, including type, incidence, and grading (per NCI-CTCAE v6.0)
Vital signs, electrocardiogram (ECG), and ECOG PS score
Serum concentrations of the toxin-conjugated antibody (SHR-A1811) and the free toxin SHR169265
Presence of anti-SHR-A1811 antibodies (ADAs) and neutralizing antibodies (NAbs)
Target Sample Size
Total Sample Size="70" Sample Size from India="35" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
17/07/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
17/07/2026
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a randomized, open-label, active-controlled, multicenter Phase 3 clinical
trial to evaluate the efficacy and safety of SHR-A1811 Versus
Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial
Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
Subjects
with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer,
fallopian tube cancer, or primary peritoneal cancer are planned to be enrolled
in the study.
Randomization will be
stratified. Eligible subjects will be randomized in a 1:1 ratio to receive
either SHR-A1811 (experimental group) or investigator’s choice of chemotherapy
(control group), which may include doxorubicin liposome, paclitaxel, topotecan,
or gemcitabine. The study will have 28 days of screening period, followed by
treatment period, end of treatment and Follow-up. Safety follow up will be done 40 days after the last dose
while long term (survival) follow up will be done once every two months.