Platinum-resistant Recurrent Ovarian Cancer (PROC)Phase 1NCT07462468
A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
A Phase 1 study testing WSK-IM02 in people with Platinum-resistant Recurrent Ovarian Cancer (PROC), run by WestVac Biopharma Co., Ltd..
Trial summary
A Phase 1, single-arm, single-center, open-label, prospective, dose-escalation, and cohort expansion study to assess the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of WSK-IM02 administered as a single agent to patients with platinum-resistant recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Platinum-resistant Recurrent Ovarian Cancer (PROC)
- What is being tested?
- WSK-IM02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 30 Sep 2027
- Phase
- Phase 1
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age ≥18 years old, ≤ 75 years old.
- Willing to voluntarily sign the informed consent form.
- Patients must have histopathologically confirmed ovarian cancer, with no requirement for additional tumor tissue biopsy during the screening period.
- Platinum-resistant recurrent ovarian cancer, with an initial response to ≥4 cycles of platinum-based therapy, followed by confirmed disease recurrence or progression 28 days to 6 months after the last platinum-containing regimen. At least one subsequent systemic therapy for recurrence/progression following platinum resistance, with ≤3 prior lines of systemic therapy (neoadjuvant + adjuvant chemotherapy/adjuvant chemotherapy counts as one chemotherapy line. Other maintenance therapies may be excluded upon investigator and sponsor 's agreement.
- ECOG performance status: 0 - 2.
- Life expectancy ≥3 months.
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- Adequate major organ function within 14 days prior to treatment : Hematology (without transfusion or hematopoietic growth factor support within 14 days): NEUT ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥80 g/L. Liver function: ALT ≤2.5 × ULN, AST ≤2.5 × ULN. In the presence of liver metastases, ALT and AST ≤5 × ULN. Renal function: Cr ≤1.5 × ULN or Ccr >50 mL/min. Coagulation function: APTT ≤1.5 × ULN, INR ≤1.5 × ULN.
- At least one measurable lesion per RECIST v1.1 criteria.
- Female subjects of childbearing potential must agree to use effective contraceptive methods from signing ICF until at least 6 months after the last dose of the investigational product.
Who cannot join
- Participation in another investigational drug trial within 4 weeks before enrollment.
- Non-epithelial ovarian cancer.
- Prior antineoplastic therapy (including chemotherapy, radiotherapy, targeted therapy, hormonal therapy, biologic therapy, immunotherapy, herbal medicine for antineoplastic purposes, or other investigational agents) within 28 days or 5 half-lives (whichever shorter) prior to first dose.
- Prior radiotherapy within 4 weeks prior to the first dose (including radiotherapy to >25% of bone marrow), or palliative localized radiotherapy to bone metastases within 2 weeks.
- Major surgery within 4 weeks prior to the first dose without complete recovery, or elective surgery planned during the trial.
- Other malignancies within the past 5 years (except stable breast cancer; except for adequately treated non-melanoma skin cancer or other solid tumors with no evidence of disease for >5 years).
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- Any toxicity from prior therapy that has not recovered to baseline or to ≤ Grade 1 per NCI-CTCAE v6.0 prior to study treatment (except those posing no safety risk per investigator, e.g., alopecia).
- Symptomatic CNS or leptomeningeal metastases, or other evidence of uncontrolled CNS or leptomeningeal metastases, and deemed inappropriate for enrollment by investigator.
- HIV positive, HbsAg positive with HBV DNA > ULN (enrollment allowed if reduced to normal post-antiviral), Anti-HCV positive with HCV RNA positive, Tp-Ab positive.
- Active infection requiring systemic anti-infective therapy (per investigator).
- Pregnant or breastfeeding.
- Known history of drug/alcohol/substance abuse, definite prior history of neurological or psychiatric disorders.
- Presence of any active autoimmune disease, history of autoimmune disease or acquired immunodeficiency syndrome.
- Corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 4 weeks prior to study drug, or requiring long-term systemic steroids during study (topical steroids allowed).
- Uncontrolled or significant cardiovascular disease, including severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA II-IV), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or myocardial infarction within 6 months prior to the first dose.
- Poorly controlled hypertension despite antihypertensive therapy (i.e., SBP ≥150 mmHg and/or DBP ≥100 mmHg).
- Uncontrolled diabetes (defined as HbA1c ≥8%, or 7% ≤ HbA1c <8% with clinical symptoms of diabetes, such as polyuria, polydipsia, polyphagia, and weight loss) or other metabolic disorders, severe gastrointestinal bleeding, severe diarrhea (CTCAE ≥ Grade 2), or severe gastrointestinal obstruction requiring intervention.
- Pulmonary disease defined as ≥ Grade 3 per NCI-CTCAE v6.0, including dyspnea at rest, requirement for continuous oxygen therapy, or history of ILD.
- Known allergy to the investigational product or its major excipients, or kanamycin.
- History of thromboembolism, cerebral infarction, hemorrhagic disorders, or evidence of bleeding tendency within 6 months prior to the first dose.
- Any other concurrent severe and/or uncontrolled medical condition that, in the investigator's judgment, renders the patient unsuitable for participation.
- Female patients of childbearing potential unwilling to use effective contraception during the trial and for 6 months post-treatment. Pregnancy test required for patients with amenorrhea on antineoplastics, even if >12 months.
- Intestinal stoma or obstruction.
- Abdominal adhesions or infection precluding intraperitoneal drug administration.
- Physical condition unsuitable for intraperitoneal injection or other factors precluding study completion per investigator.
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 1, Single-arm, Single-center, Open-label, Prospective Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
A Phase 1, single-arm, single-center, open-label, prospective, dose-escalation, and cohort expansion study to assess the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of WSK-IM02 administered as a single agent to patients with platinum-resistant recurrent ovarian cancer.
Read the detailed description
Dose-escalation part of this study will assess the safety, tolerability, PK, and preliminary efficacy of WSK-IM02 as monotherapy in eligible patients with platinum-resistant recurrent ovarian cancer. Cohort expansion part will further evaluate the Recommended Phase 2 Dose (RP2D) of WSK-IM02. RP2D decisions will be based on the totality of data, including Dose-Limiting Toxicities (DLTs), tolerability, PK, pharmacodynamics (PD), and efficacy, as available. Dose-escalation part of this study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 9 patients each within each cohort in an open-label fashion. Patients who meet eligibility criteria will be enrolled in the dose-escalation part, receiving WSK-IM02 as monotherapy via intraperitoneal injection twice weekly on Days 1, 5, 8, and 12 of repeated 14-day cycles in escalating doses. Patients will only receive WSK-IM02 for one cycle during the 28-day DLTs observation period. If a patient shows no disease progression or intolerable toxicity after completing DLTs observation, the investigator will discuss with the patient whether to continue subsequent treatment. If treatment is continued, the patient enters the treatment period. Enrollment for the next Dose Level can only begin once all patients at a given Dose Level have completed DLTs observation and have not met the termination criteria for dose escalation, and the safety has been evaluated and declared to be safe by the Safety Review Committee (SRC). After determination of Maximum Tolerated Dose (MTD) or Maximum Administrated Dose (MAD) and the expected effective Dose Level, the next part with expansion cohorts will commence to further evaluate the RP2D.
- Being tested
- WSK-IM02
- Keywords
- Ovarian cancer, Platinum-resistant recurrent ovarian cancer (PROC), cancer, Platinum-resistant, Recurrent ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WSK-IM02Drug
3.33 μg/kg, 8.33 μg/kg, or 16.67 μg/kg of WSK-IM02 as monotherapy via intraperitoneal injection.
WSK-IM02Drug
Expected effective dose level of of WSK-IM02 as monotherapy via intraperitoneal injection.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | WSK-IM02 twice weekly on Days 1, 5, 8, and 12 on repeated 14-day cycles in low, medium, and high doses. Patients will only receive WSK-IM02 for one cycle during the 28-day DLTs observation period. Receives: Drug: WSK-IM02 |
| Expansion Cohorts at RP2D | Experimental | After determination of MTD or MAD and the expected effective Dose Level, this part with expansion cohorts will commence to further evaluate the RP2D. Receives: Drug: WSK-IM02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-escalation part: Observation of DLT
DLT is defined as any clinically significant adverse event or abnormal laboratory value that is reasonably related to the investigational drug (probably, very likely, or definitely related) as defined in the protocol occurring during the 28-day DLTs observation period (Days 1-28) of Dose-escalation part. Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: 4 weeks
Dose-escalation part: Determination of the MTD or MAD
The maximum tolerated dose (MTD) is defined as the highest dose level below the maximum administered dose (MAD) that has confirmed 2 or more participants with DLT. At least 6 participants have blood samples that evaluable for the PK endpoints must be enrolled at this dose level before it may be confirmed as the MTD.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Recurrent Ovarian Cancer (PROC)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462468
- Sponsor's protocol ID
- WSKCT028
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-arm, Single-center, Open-label, Prospective Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT07462468
- Acronym / sponsor ID
- WSKCT028
- Keywords
- Ovarian cancer, Platinum-resistant recurrent ovarian cancer (PROC), cancer, Platinum-resistant, Recurrent ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Mar 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.
A Phase 1, single-arm, single-center, open-label, prospective, dose-escalation, and cohort expansion study to assess the safety, tolerability, pharmacokinetic (PK), and preliminary efficacy of WSK-IM02 administered as a single agent to patients with platinum-resistant recurrent ovarian cancer.
Detailed description
Dose-escalation part of this study will assess the safety, tolerability, PK, and preliminary efficacy of WSK-IM02 as monotherapy in eligible patients with platinum-resistant recurrent ovarian cancer. Cohort expansion part will further evaluate the Recommended Phase 2 Dose (RP2D) of WSK-IM02. RP2D decisions will be based on the totality of data, including Dose-Limiting Toxicities (DLTs), tolerability, PK, pharmacodynamics (PD), and efficacy, as available. Dose-escalation part of this study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 9 patients each within each cohort in an open-label fashion. Patients who meet eligibility criteria will be enrolled in the dose-escalation part, receiving WSK-IM02 as monotherapy via intraperitoneal injection twice weekly on Days 1, 5, 8, and 12 of repeated 14-day cycles in escalating doses. Patients will only receive WSK-IM02 for one cycle during the 28-day DLTs observation period. If a patient shows no disease progression or intolerable toxicity after completing DLTs observation, the investigator will discuss with the patient whether to continue subsequent treatment. If treatment is continued, the patient enters the treatment period. Enrollment for the next Dose Level can only begin once all patients at a given Dose Level have completed DLTs observation and have not met the termination criteria for dose escalation, and the safety has been evaluated and declared to be safe by the Safety Review Committee (SRC). After determination of Maximum Tolerated Dose (MTD) or Maximum Administrated Dose (MAD) and the expected effective Dose Level, the next part with expansion cohorts will commence to further evaluate the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: WSK-IM02WSK-IM02 twice weekly on Days 1, 5, 8, and 12 on repeated 14-day cycles in low, medium, and high doses. Patients will only receive WSK-IM02 for one cycle during the 28-day DLTs observation period. |
| Expansion Cohorts at RP2D | Experimental | Drug: WSK-IM02After determination of MTD or MAD and the expected effective Dose Level, this part with expansion cohorts will commence to further evaluate the RP2D. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, age ≥18 years old, ≤ 75 years old.
- Willing to voluntarily sign the informed consent form.
- Patients must have histopathologically confirmed ovarian cancer, with no requirement for additional tumor tissue biopsy during the screening period.
- Platinum-resistant recurrent ovarian cancer, with an initial response to ≥4 cycles of platinum-based therapy, followed by confirmed disease recurrence or progression 28 days to 6 months after the last platinum-containing regimen. At least one subsequent systemic therapy for recurrence/progression following platinum resistance, with ≤3 prior lines of systemic therapy (neoadjuvant + adjuvant chemotherapy/adjuvant chemotherapy counts as one chemotherapy line. Other maintenance therapies may be excluded upon investigator and sponsor 's agreement.
- ECOG performance status: 0 - 2.
Key exclusion criteria (25 listed)
- Participation in another investigational drug trial within 4 weeks before enrollment.
- Non-epithelial ovarian cancer.
- Prior antineoplastic therapy (including chemotherapy, radiotherapy, targeted therapy, hormonal therapy, biologic therapy, immunotherapy, herbal medicine for antineoplastic purposes, or other investigational agents) within 28 days or 5 half-lives (whichever shorter) prior to first dose.
- Prior radiotherapy within 4 weeks prior to the first dose (including radiotherapy to >25% of bone marrow), or palliative localized radiotherapy to bone metastases within 2 weeks.
- Major surgery within 4 weeks prior to the first dose without complete recovery, or elective surgery planned during the trial.
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 |
|---|---|---|
| WSK-IM023.33 μg/kg, 8.33 μg/kg, or 16.67 μg/kg of WSK-IM02 as monotherapy via intraperitoneal injection. | Drug | Monotherapy Dose Escalation |
| WSK-IM02Expected effective dose level of of WSK-IM02 as monotherapy via intraperitoneal injection. | Drug | Expansion Cohorts at RP2D |
Primary outcome
Dose-escalation part: Observation of DLT
Time frame: 4 weeks
DLT is defined as any clinically significant adverse event or abnormal laboratory value that is reasonably related to the investigational drug (probably, very likely, or definitely related) as defined in the protocol occurring during the 28-day DLTs observation period (Days 1-28) of Dose-escalation part. Adverse events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Dose-escalation part: Determination of the MTD or MAD
Time frame: 4 weeks
The maximum tolerated dose (MTD) is defined as the highest dose level below the maximum administered dose (MAD) that has confirmed 2 or more participants with DLT. At least 6 participants have blood samples that evaluable for the PK endpoints must be enrolled at this dose level before it may be confirmed as the MTD.
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 13 Mar 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 1 study testing WSK-IM02 in people with Platinum-resistant Recurrent Ovarian Cancer (PROC), run by WestVac Biopharma 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 25 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 13 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Shi Huashan (+86 028-85421141, shihuashan@westvacpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-escalation part: Observation of DLT (time frame: 4 weeks). 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 13 Mar 2026.