Ovarian CancerPhase 2/3NCT06211023
A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer
A Phase 2/3 study testing SHR-1921, carboplatin and platinum-based doublet chemotherapy in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
Trial summary
This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with 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-1921, carboplatin and platinum-based doublet chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 15 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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.
- Be able to provide fresh or archived tumour tissue.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 12 weeks.
- Adequate bone marrow reserve and organ function.
Who cannot join
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Previous or co-existing malignancies.
- Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- Subjects with active hepatitis B or active hepatitis C;
- Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
- Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
- Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer
This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- SHR-1921, carboplatin, platinum-based doublet chemotherapy
- 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-1921Drug
SHR-1921
carboplatinDrug
carboplatin AUC 4
carboplatinDrug
carboplatin AUC 5
platinum-based doublet chemotherapyDrug
platinum-based doublet chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: SHR-1921 | Experimental | Not described Receives: Drug: SHR-1921 |
| Treatment group 2: SHR-1921 + carboplatin dose level 1 | Experimental | Not described Receives: Drug: carboplatin |
| Treatment group 3: SHR-1921 + carboplatin dose level 2 | Experimental | Not described Receives: Drug: carboplatin |
| Treatment group 4: platinum-based doublet chemotherapy | Other | Not described Receives: Drug: platinum-based doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate Assessed by Investigator According to RECIST v1.1
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (5)
Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1
Measured: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Measured: Screening up to study completion, an average of 1 year
CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria
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 posted18 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy
- Masking
- None (open label)
- Enrolment
- 520 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
- NCT06211023
- Sponsor's protocol ID
- SHR-A1921-301
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06211023
- Acronym / sponsor ID
- SHR-A1921-301
- Conditions
- Ovarian Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 18 Jan 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 is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: SHR-1921 | Experimental | Drug: SHR-1921 |
| Treatment group 2: SHR-1921 + carboplatin dose level 1 | Experimental | Drug: carboplatin |
| Treatment group 3: SHR-1921 + carboplatin dose level 2 | Experimental | Drug: carboplatin |
| Treatment group 4: platinum-based doublet chemotherapy | Other | Drug: platinum-based doublet chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary participation and written informed consent.
- Be able to provide fresh or archived tumour tissue.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
Key exclusion criteria (7 listed)
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Previous or co-existing malignancies.
- Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- Subjects with active hepatitis B or active hepatitis C;
- Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
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-1921SHR-1921 | Drug | Treatment group 1: SHR-1921 |
| carboplatincarboplatin AUC 4 | Drug | Treatment group 2: SHR-1921 + carboplatin dose level 1 |
| carboplatincarboplatin AUC 5 | Drug | Treatment group 3: SHR-1921 + carboplatin dose level 2 |
| platinum-based doublet chemotherapyplatinum-based doublet chemotherapy | Drug | Treatment group 4: platinum-based doublet chemotherapy |
Primary outcome
Objective Response Rate Assessed by Investigator According to RECIST v1.1
Time frame: Screening up to study completion, an average of 1 year
5 secondary outcomes
Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1
Time frame: Screening up to study completion, an average of 1 year
Overall Survival (OS)
Time frame: Screening up to study completion, an average of 1 year
CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria
Time frame: Screening up to study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SHR-1921, carboplatin and platinum-based doublet chemotherapy in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanchao Wang (0518-81220278, yuanchao.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate Assessed by Investigator According to RECIST v1.1 (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 18 Jan 2024.