JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

Alphamab

Status and phase: Not yet enrolling; Phase 3

Conditions: Fallopian Tube Cancers; Primary Peritoneal; Ovarian Cancer

Treatments: Drug: JSKN003; Drug: Paclitaxel; Drug: Doxorubicin; Drug: Topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06751485

JSKN003-306

Details and patient eligibility

About

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.

Enrollment: 430 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Experimental: Treatment group 1:JSKN003

Experimental group

Description:

Drug: JSKN003 JSKN003 dose 1

Treatment:

Drug: JSKN003

Active Comparator: Treatment group 2: Investigator's choice of chemotherapy

Active Comparator group

Description:

Drug: Doxorubicin Doxorubicin dose 2 Drug: Paclitaxel Paclitaxel dose 3 Drug: Topotecan Topotecan dose 4

Treatment:

Drug: Topotecan

Drug: Paclitaxel

Drug: Doxorubicin