Epithelial Ovarian CancerPhase 3NCT07926048
A Study of QLS5132 in Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 3 study testing QLS5132, Liposomal Doxorubicin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this interventional study is to compare the effectiveness and safety of QLS5132 monotherapy with investigator's choice of chemotherapy in participants with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- QLS5132, Liposomal Doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jan 2030
- 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
- Female participants aged ≥ 18 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Platinum-resistant recurrent disease, defined as disease progression within 6 months (≤183 days) after the last platinum-based chemotherapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status of 0 or 1.
- Expected survival ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Negative pregnancy test for women of childbearing potential, and agreement to use effective contraception.
Who cannot join
- Prior treatment with CLDN6-targeting therapy or topoisomerase I inhibitors (e.g., topotecan, trastuzumab deruxtecan).
- Active or untreated central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with stable, treated CNS metastases may be eligible).
- Clinically significant cardiovascular disease, including QTc ≥ 470 ms, LVEF < 50%, or uncontrolled hypertension.
- Active infections (e.g., HBV, HCV, HIV, tuberculosis, syphilis).
- Active or history of autoimmune diseases requiring systemic treatment.
- Severe liver disease (Child-Pugh B or C), uncontrolled diabetes, or other severe medical conditions that may interfere with the study.
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 Phase III, Multicenter, Randomized, Open-Label, Controlled Study of QLS5132 Versus Investigator's Choice of Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
The goal of this interventional study is to compare the effectiveness and safety of QLS5132 monotherapy with investigator's choice of chemotherapy in participants with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Being tested
- QLS5132, Liposomal Doxorubicin, Paclitaxel, Topotecan
- Keywords
- CLDN6 ADC, Platinum-Resistant Ovarian Cancer, Recurrent Ovarian Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5132Drug
Intravenous infusion, Q3W (Day 1 of each 21-day cycle)
Liposomal DoxorubicinDrug
Intravenous infusion, Q4W (Day 1 of each 28-day cycle)
PaclitaxelDrug
Intravenous infusion, Q4W (Days 1, 8, 15, and 22 of each 28-day cycle)
TopotecanDrug
Intravenous infusion, Q4W (Days 1, 8, and 15 of each 28-day cycle)
| Study group | Role | What they receive |
|---|---|---|
| QLS5132 Monotherapy | Experimental | Not described Receives: Drug: QLS5132 |
| QLS5132 Investigator's Choice of Chemotherapy | Active comparator | Not described Receives: Drug: Liposomal 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 BICR
Time from randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first.
Measured: From randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first, assessed up to approximately 3 years.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization until death from any cause, assessed up to approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical 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
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926048
- Sponsor's protocol ID
- QLS5132-301
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of QLS5132 Versus Investigator's Choice of Chemotherapy in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT07926048
- Acronym / sponsor ID
- QLS5132-301
- Keywords
- CLDN6 ADC, Platinum-Resistant Ovarian Cancer, Recurrent Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Nov 2026 (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.
The goal of this interventional study is to compare the effectiveness and safety of QLS5132 monotherapy with investigator's choice of chemotherapy in participants with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS5132 Monotherapy | Experimental | Drug: QLS5132 |
| QLS5132 Investigator's Choice of Chemotherapy | Active comparator | Drug: Liposomal 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 (8 listed)
- Female participants aged ≥ 18 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Platinum-resistant recurrent disease, defined as disease progression within 6 months (≤183 days) after the last platinum-based chemotherapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status of 0 or 1.
Key exclusion criteria (6 listed)
- Prior treatment with CLDN6-targeting therapy or topoisomerase I inhibitors (e.g., topotecan, trastuzumab deruxtecan).
- Active or untreated central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with stable, treated CNS metastases may be eligible).
- Clinically significant cardiovascular disease, including QTc ≥ 470 ms, LVEF < 50%, or uncontrolled hypertension.
- Active infections (e.g., HBV, HCV, HIV, tuberculosis, syphilis).
- Active or history of autoimmune diseases requiring systemic 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 |
|---|---|---|
| QLS5132Intravenous infusion, Q3W (Day 1 of each 21-day cycle) | Drug | QLS5132 Monotherapy |
| Liposomal DoxorubicinIntravenous infusion, Q4W (Day 1 of each 28-day cycle) | Drug | QLS5132 Investigator's Choice of Chemotherapy |
| PaclitaxelIntravenous infusion, Q4W (Days 1, 8, 15, and 22 of each 28-day cycle) | Drug | QLS5132 Investigator's Choice of Chemotherapy |
| TopotecanIntravenous infusion, Q4W (Days 1, 8, and 15 of each 28-day cycle) | Drug | QLS5132 Investigator's Choice of Chemotherapy |
Primary outcome
Progression-Free Survival (PFS) Assessed by BICR
Time frame: From randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first, assessed up to approximately 3 years.
Time from randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first.
Overall Survival (OS)
Time frame: From randomization until death from any cause, assessed up to approximately 3 years.
Time from randomization to death from any cause.
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 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLS5132, Liposomal Doxorubicin and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Qilu Pharmaceutical 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 8 inclusion and 6 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 9 Nov 2026. 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 Tao Zhu, Master (13858065156, zhutao@zjcc.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 BICR (time frame: From randomization to the first documented disease progression as assessed by blinded independent central review (BICR) using RECIST v1.1, or death from any cause, whichever occurs first, assessed up to approximately 3 years.). The study lists 2 primary outcomes in all. 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 Nov 2026.