A Phase 1 Clinical Study to Evaluate the Safety and Efficacy of WSK-IM02 in Patients With Platinum-resistant Recurrent Ovarian Cancer.

NCT07462468 | Not Yet Recruiting Phase 1

• 1 other identifier: WSKCT028
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Platinum-resistant Recurrent Ovarian Cancer (PROC)

Keywords

Ovarian cancer; Platinum-resistant recurrent ovarian cancer (PROC); cancer; Platinum-resistant; Recurrent ovarian cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks

Study Arms (2)

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.

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.

Drug: WSK-IM02

Interventions

WSK-IM02 DRUG

3.33 μg/kg, 8.33 μg/kg, or 16.67 μg/kg of WSK-IM02 as monotherapy via intraperitoneal injection.

Monotherapy Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Shi Huashan

CONTACT

+86 028-85421141; shihuashan@westvacpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-02