JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

January 26, 2026 updated by: Shanghai JMT-Bio Inc.

A Phase III Trial to Evaluate the Efficacy and Safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

The study is being conducted to evaluate the efficacy and safety of JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Trials Information Group Officer
  • Phone Number: 86-0311-69085587
  • Email: ctr-contact@cspc.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age≥18 years old.
  • Unresectable locally advanced or distant metastatic BRAFV600E wild-type colorectal cancer diagnosed histologically or cytologically.
  • After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure).
  • HER2-positive (defined as IHC3+ or IHC 2+/FISH +).
  • According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one assessable lesion, assessable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed).
  • ECOG PS of 0-1.
  • Expected survival ≥ 3 months.
  • Participants with adequate organ functions.
  • Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.
  • Voluntarily agree to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Participants who have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.
  • Participants with brain metastasis or spinal cord compression at screening.
  • Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1.
  • There are obvious clinical manifestations of gastrointestinal abnormalities, including but not limited to: having experienced intestinal obstruction or symptoms and signs of intestinal obstruction within 3 months prior to administration; having had gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 3 months prior to administration; having experienced gastrointestinal bleeding of CTCAE grade ≥ 3 within 3 months prior to administration, or having had gastrointestinal bleeding within the previous 1 month.
  • Participants who have undergone major surgery or had invasive intervention within 28 days before the randomization. Or those who plan to undergo systematic or local tumor resection during the trial.
  • Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.
  • Participants who have used any Chinese herbal medicine or Chinese patent medicine approved by the national drug regulatory authority for its anti-cancer properties within the previous 14 days (regardless of the type of cancer); have received palliative radiotherapy within the 14 days prior to randomization; have received systemic anti-tumor treatment within 4 weeks or 5 half-life (whichever is shorter but at least 2 weeks) prior to randomization.
  • Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
  • Participants who have active bacterial, fungal or viral infections 14 days before the randomization.
  • Within the 14 days before the randomization, participants who had a situation where there was an uncontrollable need for frequent drainage or medical intervention in the serous cavity effusion.
  • Participant with positive hepatitis B surface antigen (HBsAg) and HBV-DNA is higher than 500 IU/mL (or 2500 copies/ml) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and HCV-RNA is higher than 1000 copies/ml or UNL (whichever is lower).
  • Has activity or a history of interstitial lung disease at any stage and/or pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease/pneumonia at screening.
  • Has a history of severe cardiovascular disease.
  • History of any other malignant tumors within 5 years.
  • Pregnant or breastfeeding women.
  • Otherwise considered inappropriate for the study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: JSKN003
Drug: JSKN003
JSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W).
Active Comparator: Physician choiced treatment
Drug: Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.
TAS-102(35 mg/m2, maximum 80 mg per dose), twice daily (BID), once every 4 weeks (Q4W); or Regorafenib 160mg, once daily (QD), once every 4 weeks (Q4W); or Fruquintinib 5mg once daily (QD), once every 4 weeks (Q4W).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progressive Free Survive (PFS) assessed by Independent Review Committee
Time Frame: Every 6 weeks, up to 3 years
Every 6 weeks, up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Progressive Free Survive (PFS) assessed by the Investigator
Time Frame: Every 6 weeks, up to 3 years
Every 6 weeks, up to 3 years
Objective response rate (ORR) assessed by the Investigator or IRC
Time Frame: Every 6 weeks, up to 3 years
Every 6 weeks, up to 3 years
Duration of Response (DOR) assessed by the Investigator or IRC
Time Frame: Every 6 weeks, up to 3 years
Every 6 weeks, up to 3 years
Incidence and severity of TEAE and SAE
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Blood concentration of JSKN003
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Blood concentration of total antibodies for JSKN003
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Blood concentration of free toxins for JSKN003
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Anti-drug antibodies (ADA) related to JSKN003
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai JMT-Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSKN003-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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