Metastatic Colorectal CancerPhase 2NCT07314294
Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
A Phase 2 study testing EMB-01 1600 mg administered once weekly throughout the study and EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter in people with Metastatic Colorectal Cancer, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 2 sites in China.
Trial summary
This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- EMB-01 1600 mg administered once weekly throughout the study and EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2025to 30 Jun 2028
- Phase
- Phase 2
- 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
- Able to understand and willing to sign the informed consent form (ICF).
- Male or female aged ≥ 18 years.
- Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1.
- ECOG performance status ≤ 1.
- Willing to provide a fresh tumor biopsy sample or a stored sample obtained within the past 2 years.If no eligible archived tumor tissue sample is available and the patient's clinical condition is not suitable for biopsy, the patient may still be allowed to participate in screening upon confirmation and agreement between the investigator and the sponsor.
- Adequate organ function prior to the first study treatment.
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- Prior anti-cancer treatment:
- Must have progressed on or been intolerant to at least first- or second-line systemic therapy for metastatic colorectal cancer. Prior therapy must include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, and bevacizumab with or without cetuximab. Patients should not have received TAS-102, fruquinitinib, or regorafenib.
- Any approved or investigational anti-cancer therapy (chemotherapy, immunotherapy, hormone therapy except for replacement therapy, testosterone, or oral contraceptives, biological therapy, targeted therapy) must be discontinued ≥ 4 weeks or 5 half-lives (whichever is shorter) before first study treatment.
- Local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines (e.g., tegafur, capecitabine) must be stopped ≥ 2 weeks before first study treatment; therapeutic radiopharmaceuticals must not have been administered within 8 weeks prior to the first dose of EMB-01.
- Women of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from clinical screening and continue during study treatment until 3 months after the last EMB-01 dose.
Who cannot join
- Presence of KRAS/NRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity (IHC3+ or amplification), RET fusion, NTRK fusion, or other molecular mutations affecting anti-EGFR or cMET efficacy(Investigator and sponsor discussion recommended if applicable), based on central lab testing or prior treatment history.
- Life expectancy < 3 months.
- Residual adverse events (AEs) from prior anti-cancer therapy > CTCAE grade 1.
- Primary CNS malignancy or symptomatic CNS metastases (brain, leptomeningeal, or arachnoid). Patients with asymptomatic CNS metastases may be eligible if no local radiotherapy is needed, or radiotherapy was completed ≥ 4 weeks prior to study treatment.
- Pregnant or breastfeeding women.
- Major surgery within 28 days prior to screening. Surgical wounds must be fully healed.
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- Idiopathic pulmonary fibrosis, unresolved active or chronic inflammatory lung disease, or history of interstitial lung disease (ILD). Patients with resolved radiation pneumonitis may be eligible.
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or severe skin infections.
- Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates (ADCs).
- Prior EGFR inhibitor therapy discontinued due to severe skin toxicity.
- Other significant medical conditions, psychiatric or psychological disorders, or familial/endemically high-risk diseases that may interfere with study assessments, treatment, follow-up, adherence, or increase risk of treatment-related complications.
- Any condition deemed by the investigator to make study participation not in the patient's best interest or likely to interfere, limit, or confound study assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen
- Not yet recruiting
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou
Yanhong Deng
About this study
Official title: A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent/Metastatic Colorectal Cancer
This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.
Read the detailed description
This is a randomized, open-label Phase II dose-optimization study of EMB-01 in patients with metastatic colorectal cancer (CRC). The study will enroll patients with recurrent/metastatic KRAS/BRAF wild-type left-sided CRC who have progressed, relapsed, or become intolerant after first- or second-line systemic therapy. Patients will be stratified by prior anti-EGFR therapy and randomized 1:1 into two groups.
Group 1 will receive EMB-01 1600 mg once weekly (QW). Group 2 will receive EMB-01 1600 mg QW for the first 6 weeks, followed by 1600 mg once every two weeks (Q2W).
Tumor assessments will follow RECIST v1.1 using CT and/or MRI. Baseline imaging will be performed within 28 days before enrollment. During the study, imaging and efficacy assessments will occur every 6 weeks for the first 12 cycles, and every 3 cycles thereafter. All imaging procedures must be consistent with baseline. Assessments will be performed by the investigator, with retrospective independent review if needed.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- EMB-01 1600 mg administered once weekly throughout the study, EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-01 1600 mg administered once weekly throughout the studyDrug
Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study.
EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafterDrug
Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) for the first 6 weeks, followed by 1600 mg administered every 2 weeks (Q2W) thereafter.
| Study group | Role | What they receive |
|---|---|---|
| EMB-01 1600 mg once weekly (QW) | Experimental | EMB-01 1600 mg administered once weekly throughout the study Receives: Drug: EMB-01 1600 mg administered once weekly throughout the study |
| EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W) | Experimental | EMB-01 1600 mg once weekly for the first 6 weeks, then 1600 mg every 2 weeks thereafter Receives: Drug: EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate of EMB-01 at different dose levels
Measured: Drom the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Measured: Screening up to follow-up (30 days after the last dose)
Secondary outcomes (6)
Best Overall Response (BOR) as assessed by RECIST v1.1
Best Overall Response (BOR) as assessed by RECIST v1.1
Measured: from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Cmax
PK parameter Cmax of EMB-01 at different dose levels
Measured: Up to 3 months after first study drug administration
ADA
Incidence of anti-drug antibodies (ADA) of EMB-01 at different dose levels
Measured: Up to the 30-day safety follow-up visit after EOT
Ctrough
Measured trough concentration (Ctrough) of EMB-01
Measured: Through treatment completion, an average of 1 year
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Measured: up to 3 months after first study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: up to 3 months after first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start18 Dec 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314294
- Sponsor's protocol ID
- EMB01X204
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent/Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07314294
- Acronym / sponsor ID
- EMB01X204
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jan 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.
This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.
Detailed description
This is a randomized, open-label Phase II dose-optimization study of EMB-01 in patients with metastatic colorectal cancer (CRC). The study will enroll patients with recurrent/metastatic KRAS/BRAF wild-type left-sided CRC who have progressed, relapsed, or become intolerant after first- or second-line systemic therapy. Patients will be stratified by prior anti-EGFR therapy and randomized 1:1 into two groups.
Group 1 will receive EMB-01 1600 mg once weekly (QW). Group 2 will receive EMB-01 1600 mg QW for the first 6 weeks, followed by 1600 mg once every two weeks (Q2W).
Tumor assessments will follow RECIST v1.1 using CT and/or MRI. Baseline imaging will be performed within 28 days before enrollment. During the study, imaging and efficacy assessments will occur every 6 weeks for the first 12 cycles, and every 3 cycles thereafter. All imaging procedures must be consistent with baseline. Assessments will be performed by the investigator, with retrospective independent review if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMB-01 1600 mg once weekly (QW) | Experimental | Drug: EMB-01 1600 mg administered once weekly throughout the studyEMB-01 1600 mg administered once weekly throughout the study |
| EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W) | Experimental | Drug: EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafterEMB-01 1600 mg once weekly for the first 6 weeks, then 1600 mg every 2 weeks thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand and willing to sign the informed consent form (ICF).
- Male or female aged ≥ 18 years.
- Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1.
- ECOG performance status ≤ 1.
- Willing to provide a fresh tumor biopsy sample or a stored sample obtained within the past 2 years.If no eligible archived tumor tissue sample is available and the patient's clinical condition is not suitable for biopsy, the patient may still be allowed to participate in screening upon confirmation and agreement between the investigator and the sponsor.
Key exclusion criteria (12 listed)
- Presence of KRAS/NRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity (IHC3+ or amplification), RET fusion, NTRK fusion, or other molecular mutations affecting anti-EGFR or cMET efficacy(Investigator and sponsor discussion recommended if applicable), based on central lab testing or prior treatment history.
- Life expectancy < 3 months.
- Residual adverse events (AEs) from prior anti-cancer therapy > CTCAE grade 1.
- Primary CNS malignancy or symptomatic CNS metastases (brain, leptomeningeal, or arachnoid). Patients with asymptomatic CNS metastases may be eligible if no local radiotherapy is needed, or radiotherapy was completed ≥ 4 weeks prior to study treatment.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| EMB-01 1600 mg administered once weekly throughout the studyParticipants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study. | Drug | EMB-01 1600 mg once weekly (QW) |
| EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafterParticipants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) for the first 6 weeks, followed by 1600 mg administered every 2 weeks (Q2W) thereafter. | Drug | EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W) |
Primary outcome
Objective response rate
Time frame: Drom the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Objective response rate of EMB-01 at different dose levels
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Time frame: Screening up to follow-up (30 days after the last dose)
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
6 secondary outcomes
Best Overall Response (BOR) as assessed by RECIST v1.1
Time frame: from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Cmax
Time frame: Up to 3 months after first study drug administration
ADA
Time frame: Up to the 30-day safety follow-up visit after EOT
Ctrough
Time frame: Through treatment completion, an average of 1 year
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Time frame: up to 3 months after first study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: up to 3 months after first study drug administration
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 Mar 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMB-01 1600 mg administered once weekly throughout the study and EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter in people with Metastatic Colorectal Cancer, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 2 sites in China.
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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mingfei Zhang (+8618621952423, mfzhang@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Drom the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months). The study lists 2 primary outcomes in all. 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 Mar 2026.