Ovarian CancerPhase 3NCT06394492
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
A Phase 3 study testing SHR-A1921, Doxorubicin and Paclitaxel in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- SHR-A1921, Doxorubicin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesChina
- Study dates
- 10 May 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and written informed consent.
- 18 years and older, female.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Patients must have platinum-resistant disease
- Be able to provide fresh or archived tumour tissue.
- At least one measurable lesion according to RECIST v1.1.
Show all 10Show fewer
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 12 weeks.
- Adequate bone marrow reserve and organ function.
- Contraception is required during the trial.
Who cannot join
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Previous or co-existing malignancies.
- Current or History of ILD.
- Clinical symptoms or diseases of the heart that are not well controlled.
- Arterial/venous thrombosis events occurred before the first dose.
- Grade ≥2 bleeding events of CTCAE occurred before the first dose.
Show all 15Show fewer
- Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
- Patients with intestinal obstruction or parenteral nutrition before the first dose.
- Serious infection before the first dose.
- Active hepatitis B or active hepatitis C.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
- Other inappropriate situation considered by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Lingyin Wu, Doctor
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Tao Zhu, Doctor
About this study
Official title: A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- SHR-A1921, Doxorubicin, Paclitaxel, Topotecan
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1921Drug
SHR-A1921 dose 1
DoxorubicinDrug
Doxorubicin dose 2
PaclitaxelDrug
Paclitaxel dose 3
TopotecanDrug
Topotecan dose 4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: SHR-A1921 | Experimental | Not described Receives: Drug: SHR-A1921 |
| Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Not described Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (7)
Overall Survival (OS)
Measured: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria
Measured: Screening up to study completion, an average of 1 year
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
Measured: Screening up to study completion, an average of 1 year
Adverse Events
Measured: Screening up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start10 May 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394492
- Sponsor's protocol ID
- SHR-A1921-303
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06394492
- Acronym / sponsor ID
- SHR-A1921-303
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: SHR-A1921 | Experimental | Drug: SHR-A1921 |
| Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Drug: Doxorubicin, Drug: Paclitaxel, Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation and written informed consent.
- 18 years and older, female.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Patients must have platinum-resistant disease
- Be able to provide fresh or archived tumour tissue.
Key exclusion criteria (15 listed)
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Previous or co-existing malignancies.
- Current or History of ILD.
- Clinical symptoms or diseases of the heart that are not well controlled.
- Arterial/venous thrombosis events occurred before the first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-A1921SHR-A1921 dose 1 | Drug | Treatment group 1: SHR-A1921 |
| DoxorubicinDoxorubicin dose 2 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
| PaclitaxelPaclitaxel dose 3 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
| TopotecanTopotecan dose 4 | Drug | Treatment group 2: Investigator's choice of chemotherapy |
Primary outcome
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
7 secondary outcomes
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria
Time frame: Screening up to study completion, an average of 1 year
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
Time frame: Screening up to study completion, an average of 1 year
Adverse Events
Time frame: Screening up to study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-A1921, Doxorubicin and Paclitaxel in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuni Wang (+86 021-61053363, shuni.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1 (time frame: Screening up to study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.