JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

NCT06751485 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: JSKN003-306
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancers

Keywords

JSKN003-306

Outcome Measures

Primary Outcomes (1)

• 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

  Up to approximately 22 months

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 22 months

• Overall Response Rate (ORR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 22 months

• Duration of Response (DoR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 22 months

• Disease Control Rate (DCR) evaluated by BIRC as per RECIST 1.1

  Up to approximately 22 months

• PFS evaluated by the Investigator as per RECIST 1.1

  Up to approximately 22 months

Study Arms (2)

Experimental: Treatment group 1:JSKN003

EXPERIMENTAL

Drug: JSKN003 JSKN003 dose 1

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

Drug: Doxorubicin; Drug: Paclitaxel; Drug: Topotecan

Interventions

JSKN003 DRUG

Experimental drug

Experimental: Treatment group 1:JSKN003

Doxorubicin DRUG

Active Comparator

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

Paclitaxel DRUG

Active Comparator

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

Topotecan DRUG

Active Comparator

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Doxorubicin; Paclitaxel; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Lingying Wu, Doctor

CONTACT

8610-87788495; wulingying@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the efficacy and safety of JSKN003 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: December 30, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-12