Health TrialsbyHealthPanel

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

ConditionsOvarian CancerPrimary PeritonealFallopian Tube Cancers
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation and written informed consent.

≥18 years;

Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Confirmed platinum-resistant relapse.

Disqualifiers

Primary platinum-refractory disease.

Active central nervous system metastases.

Uncontrolled pleural effusion.

Previous treatment with topoisomerase I inhibitor ADCs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JSKN003

    Drug

    Experimental drug

  • Doxorubicin

    Drug

    Active Comparator

  • Paclitaxel

    Drug

    Active Comparator

  • Topotecan

    Drug

    Active Comparator

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Experimental: Treatment group 1:JSKN003Experimental treatment 1 intervention
Group B: Active Comparator: Treatment group 2: Investigator's choice of chemotherapyActive comparator 3 interventions

Trial outcomes

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

Time frame
Up to approximately 22 months

Secondary outcomes

1

Overall Survival (OS)

OS was defined as the time from the date of first dose until the date of death from any cause

Time frame
Up to approximately 22 months
2

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

ORR was defined as the proportion of subjects achieving Complete Response (CR) or Partial Response (PR)

Time frame
Up to approximately 22 months
3

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

DOR was defined as the time from CR/PR to PD or death from any cause, whichever occurs first

Time frame
Up to approximately 22 months
4

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

DCR was defined as the proportion of subjects whose best overall response is CR, PR, or Stable Disease (SD)

Time frame
Up to approximately 22 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: