Ovarian CancerPhase 3NCT06751485
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer
A Phase 3 study testing JSKN003, Doxorubicin and Paclitaxel in people with Ovarian Cancer and Primary Peritoneal, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Trial summary
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancers
- What is being tested?
- JSKN003, Doxorubicin and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 30 Dec 2027
- 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;
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Confirmed platinum-resistant relapse.
- According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.
- Expected survival of more than 3 months.
Show all 9Show fewer
- ECOG performance status score of 0 or 1.
- Adequate organ function.
- Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.
Who cannot join
- Primary platinum-refractory disease.
- Active central nervous system metastases.
- Uncontrolled pleural effusion.
- Previous treatment with topoisomerase I inhibitor ADCs.
- Other malignant tumors within 5 years.
- Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease.
Show all 11Show fewer
- Uncontrolled comorbidities.
- Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
- History of allogeneic bone marrow or organ transplantation.
- Allergic reactions or hypersensitivity to antibody drugs.
- Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.
- Conditions
- Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancers
- Being tested
- JSKN003, Doxorubicin, Paclitaxel, Topotecan
- Keywords
- JSKN003-306
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN003Drug
Experimental drug
DoxorubicinDrug
Active Comparator
PaclitaxelDrug
Active Comparator
TopotecanDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment group 1:JSKN003 | Experimental | Drug: JSKN003 JSKN003 dose 1 Receives: Drug: JSKN003 |
| Active Comparator: Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Drug: Doxorubicin Doxorubicin dose 2
Drug: Paclitaxel Paclitaxel dose 3
Drug: Topotecan Topotecan dose 4 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 Independent Review Committee (BIRC) as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Measured: Up to approximately 22 months
Secondary outcomes (10)
Overall Survival (OS)
OS was defined as the time from the date of first dose until the date of death from any cause
Measured: Up to approximately 22 months
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Measured: Up to approximately 22 months
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Measured: Up to approximately 22 months
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Measured: Up to approximately 22 months
PFS evaluated by the Investigator as per RECIST 1.1
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
Measured: Up to approximately 22 months
ORR evaluated by the Investigator as per RECIST 1.1
ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)
Measured: Up to approximately 22 months
DoR evaluated by the Investigator as per RECIST 1.1
DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first
Measured: Up to approximately 22 months
DCR evaluated by the Investigator as per RECIST 1.1
DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)
Measured: Up to approximately 22 months
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
CA-125 Response Rate was assessed according to the GCIG criteria
Measured: Up to approximately 22 months
Number and Severity of Treatment-emergent Adverse Events (TEAEs)
The incidence and severity of TEAEs and TRAEs (Treatment-related Adverse Events, graded according to NCI CTCAE 5.0), Serious AEs (SAEs), laboratory tests, etc.
Measured: Up to approximately 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (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 Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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 JSKN003 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751485
- Sponsor's protocol ID
- JSKN003-306
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT06751485
- Acronym / sponsor ID
- JSKN003-306
- Conditions
- Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancers
- Keywords
- JSKN003-306
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Dec 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 JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube 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 JSKN003 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment group 1:JSKN003 | Experimental | Drug: JSKN003Drug: JSKN003 JSKN003 dose 1 |
| Active Comparator: Treatment group 2: Investigator's choice of chemotherapy | Active comparator | Drug: Doxorubicin, Drug: Paclitaxel, Drug: TopotecanDrug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and written informed consent.
- ≥18 years;
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Confirmed platinum-resistant relapse.
- According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.
Key exclusion criteria (11 listed)
- Primary platinum-refractory disease.
- Active central nervous system metastases.
- Uncontrolled pleural effusion.
- Previous treatment with topoisomerase I inhibitor ADCs.
- Other malignant tumors within 5 years.
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 |
|---|---|---|
| JSKN003Experimental drug | Drug | Experimental: Treatment group 1:JSKN003 |
| DoxorubicinActive Comparator | Drug | Active Comparator: Treatment group 2: Investigator's choice of chemotherapy |
| PaclitaxelActive Comparator | Drug | Active Comparator: Treatment group 2: Investigator's choice of chemotherapy |
| TopotecanActive Comparator | Drug | Active Comparator: Treatment group 2: Investigator's choice of chemotherapy |
Primary outcome
Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1
Time frame: Up to approximately 22 months
PFS was defined as the time from randomization until the date of progressive disease or death, whichever occurred first
10 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 22 months
Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1
Time frame: Up to approximately 22 months
Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1
Time frame: Up to approximately 22 months
Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1
Time frame: Up to approximately 22 months
PFS evaluated by the Investigator as per RECIST 1.1
Time frame: Up to approximately 22 months
ORR evaluated by the Investigator as per RECIST 1.1
Time frame: Up to approximately 22 months
DoR evaluated by the Investigator as per RECIST 1.1
Time frame: Up to approximately 22 months
DCR evaluated by the Investigator as per RECIST 1.1
Time frame: Up to approximately 22 months
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
Time frame: Up to approximately 22 months
Number and Severity of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 22 months
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 31 Dec 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JSKN003, Doxorubicin and Paclitaxel in people with Ovarian Cancer and Primary Peritoneal, run by Jiangsu Alphamab 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 31 Dec 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 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 Lingying Wu, Doctor (8610-87788495, wulingying@csco.org.cn), 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 Independent Review Committee (BIRC) as per RECIST 1.1 (time frame: Up to approximately 22 months). 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 31 Dec 2024.