HER2-positive Colorectal CancerPhase 3NCT07384377
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
A Phase 3 study testing JSKN003 and Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib. in people with HER2-positive Colorectal Cancer, run by Shanghai JMT-Bio Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Colorectal Cancer
- What is being tested?
- JSKN003 and Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2026to 15 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- HER2-positive Colorectal Cancer
- Being tested
- JSKN003, Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN003Drug
JSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W).
Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| JSKN003 | Active comparator | Not described Receives: Drug: JSKN003 |
| Physician choiced treatment | Active comparator | Not described Receives: Drug: Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Free Survive (PFS) assessed by Independent Review Committee
Measured: Every 6 weeks, up to 3 years
Secondary outcomes (9)
Progressive Free Survive (PFS) assessed by the Investigator
Measured: Every 6 weeks, up to 3 years
Objective response rate (ORR) assessed by the Investigator or IRC
Measured: Every 6 weeks, up to 3 years
Duration of Response (DOR) assessed by the Investigator or IRC
Measured: Every 6 weeks, up to 3 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Incidence and severity of TEAE and SAE
Measured: Up to approximately 3 years
Blood concentration of JSKN003
Measured: Up to approximately 3 years
Blood concentration of total antibodies for JSKN003
Measured: Up to approximately 3 years
Blood concentration of free toxins for JSKN003
Measured: Up to approximately 3 years
Anti-drug antibodies (ADA) related to JSKN003
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start6 Feb 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, randomized, multi-center Phase III clinical study.
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384377
- Sponsor's protocol ID
- JSKN003-005
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07384377
- Acronym / sponsor ID
- JSKN003-005
- Conditions
- HER2-positive Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, multi-center Phase III clinical study.
| Arm | Type | Receives |
|---|---|---|
| JSKN003 | Active comparator | Drug: JSKN003 |
| Physician choiced treatment | Active comparator | Drug: Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSKN003JSKN003 (6.3 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W). | Drug | JSKN003 |
| 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). | Drug | Physician choiced treatment |
Primary outcome
Progressive Free Survive (PFS) assessed by Independent Review Committee
Time frame: Every 6 weeks, up to 3 years
9 secondary outcomes
Progressive Free Survive (PFS) assessed by the Investigator
Time frame: 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
Duration of Response (DOR) assessed by the Investigator or IRC
Time frame: Every 6 weeks, up to 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Incidence and severity of TEAE and SAE
Time frame: Up to approximately 3 years
Blood concentration of JSKN003
Time frame: Up to approximately 3 years
Blood concentration of total antibodies for JSKN003
Time frame: Up to approximately 3 years
Blood concentration of free toxins for JSKN003
Time frame: Up to approximately 3 years
Anti-drug antibodies (ADA) related to JSKN003
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JSKN003 and Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib. in people with HER2-positive Colorectal Cancer, run by Shanghai JMT-Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive Free Survive (PFS) assessed by Independent Review Committee (time frame: Every 6 weeks, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.