Unresectable/Metastatic Colorectal CancerPhase 1NCT07649655

EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer

A Phase 1 study testing EMB-01, Irinotecan and TAS-102 in people with Unresectable/Metastatic Colorectal Cancer, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Unresectable/Metastatic Colorectal Cancer
What is being tested?: EMB-01, Irinotecan and TAS-102
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesChina
Study dates: 30 Sep 2026to 31 Dec 2028
Phase: Phase 1
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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Male or female patients aged ≥ 18 and < 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.
3. ECOG performance status ≤ 1. 4. Agrees to provide archival tumor tissue (formalin-fixed paraffin-embedded, collected within 18 months) or newly obtained biopsy tissue. If no eligible archival tissue is available and the patient's clinical condition is not suitable for biopsy, the patient may be screened after confirmation and agreement between the investigator and sponsor.
5. Adequate organ function within 14 days prior to the first dose of study treatment 6. Prior anti-tumor therapy:
Patients who received any approved or investigational anti-cancer therapy must have discontinued such therapy at least 4 weeks prior to the first dose of study treatment or 5 half-lives of the agent, whichever is shorter.
Patients who received local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines must have discontinued such therapy at least 2 weeks prior to the first dose of study treatment. No therapeutic radiopharmaceuticals within 8 weeks prior to the first dose of EMB-01.
Prior anti-tumor therapy requirements by combination regimen:

Show all 11Show fewer

Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102/fruquintinib/regorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.
Arm C (mFOLFOX6): No prior oxaliplatin-based chemotherapy and no prior anti-EGFR therapy.
Arm D (FOLFIRI): No prior irinotecan-based chemotherapy and no prior anti-EGFR therapy.
7. Female patients of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from the screening period, continue such methods during study treatment, and until 3 months after the last dose of EMB-01 (for Arm B: 6 months after last TAS-102 dose for both sexes; for Arm C: 9 months after last oxaliplatin dose for females, 6 months for males; for Arm A/D: 6 months after last chemotherapy dose for females, 3 months for males).
8. Able to swallow and retain oral medications, and has adequate venous access.

Who cannot join

1. Expected survival < 3 months. 2. Presence of KRAS/NRAS (exons 2, 3, 4), BRAF V600, HER2 positivity (IHC3+ and/or amplification), RET/NTRK fusion, or other molecular alterations that may affect anti-EGFR or cMET therapy efficacy, as detected by central laboratory testing at screening or documented in prior treatment history. (Discussion between investigator and sponsor in writing is recommended if applicable.) 3. Persistent adverse events (AEs) from prior anti-tumor therapy > Grade 2 per CTCAE v5.0, except alopecia, Grade 2 fatigue, or Grade 2 peripheral neuropathy.
4. Primary central nervous system (CNS) malignancy or symptomatic CNS/leptomeningeal metastases. Asymptomatic CNS metastases are allowed if no local radiotherapy is required, or if radiotherapy was completed ≥ 4 weeks prior to first study dose.
5. Prior treatment with anti-EGFR × cMET bispecific antibody or bispecific ADC. 6. Discontinuation of EGFR inhibitors due to skin toxicity. 7. History of life-threatening hypersensitivity, or known allergy to recombinant proteins/excipients in EMB-01 or any study treatment contraindication.
8. Systemic corticosteroids (> 10 mg prednisone equivalent/day) or other immunosuppressants required within 14 days prior to first dose, regardless of autoimmune disease. Inhaled/topical/ocular/nasal/joint steroids are permitted; adrenal replacement steroids are allowed at >10 mg/day if no active autoimmune disease.
9. Severe/uncontrolled cardiac disease requiring treatment 10. Use or planned use of QT-prolonging or rhabdomyolysis-inducing drugs during screening through study end (only Arm C); or known CYP3A4/UGT1A1 strong inhibitors/CYP3A4 inducers/anticholinesterase neuromuscular blockers (only Arms A/D).
10. Rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (only Arm B).
11. Other serious uncontrolled medical, psychiatric, or familial/endemic conditions that may interfere with study assessments, adherence, or safety (investigator's assessment).
12. Any condition that, in the investigator's opinion, makes study participation not in the patient's best interest or confounds study evaluations.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Wu contact

86-21-61951000

ywu@epimab.com

China2 sites, 2 recruiting

Beijing Cancer Hospital
Beijing, Beijing Municipality
Jian Li
Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yanhong Deng
Recruiting

Other trials in China

About this study

Official title: A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer

This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.

Conditions: Unresectable/Metastatic Colorectal Cancer
Being tested: EMB-01, Irinotecan, TAS-102, mFOLFOX6, FOLFIRI
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-01Drug
EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
IrinotecanDrug
Irinotecan will be administered as intravenous infusion.
TAS-102Drug
TAS-102 will be administered orally.
mFOLFOX6Drug
mFOLFOX6 will be administered as intravenous infusion.
FOLFIRIDrug
FOLFIRI will be administered as intravenous infusion.

Study groups in NCT07649655
Study group	Role	What they receive
Arm A	Experimental	EMB-01 + Irinotecan Receives: Drug: EMB-01; Drug: Irinotecan
Arm B	Experimental	EMB-01 + TAS-102 Receives: Drug: EMB-01; Drug: TAS-102
Arm C	Experimental	EMB-01 + 5-Flurouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Receives: Drug: EMB-01; Drug: mFOLFOX6
Arm D	Experimental	EMB-01 + 5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Receives: Drug: EMB-01; Drug: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and severity of adverse events (AEs)
Safety profile of EMB-01 in combination with chemotherapy will be evaluated by the incidence, severity, seriousness, and relationship of AEs, graded per CTCAE v5.0
Measured: From enrollment up to 30 days after last dose of study treatment
Incidence of dose-limiting toxicities (DLTs)
DLTs will be assessed according to protocol-defined criteria during the first treatment cycle of EMB-01 in combination with chemotherapy regimens
Measured: Up to Cycle 1 (28 days)
Tolerability of EMB-01 in combination with chemotherapy
Outcome Measure: Treatment interruption due to intolerability and relative dose intensity (RDI)
Measured: From first dose to 30 days after last dose, up to 2 years
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2CD)
Determination of the MTD and/or RP2CD of EMB-01 in combination with chemotherapy
Measured: Through study completion, up to 2 years

Secondary outcomes (9)

Cmax
Measured: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Ctrough
Measured: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Objective response rate (ORR)
defined as the proportion of participants achieving CR or PR per RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years.
Disease control rate (DCR)
defined as the proportion of participants achieving CR, PR, or SD per RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Best Overall Response (BOR)
defined as the best response achieved at any time during study treatment, per RECIST v1.1, categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Duration of Response (DOR)
defined as the time from the first documentation of objective response (CR or PR per RECIST v1.1) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Clinical Benefit Rate (CBR)
defined as the proportion of participants achieving CR, PR, or durable SD (≥ 6 months) per RECIST v1.1.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Progression-Free Survival (PFS)
defined as the time from the first study treatment dose to the first documentation of progressive disease (PD per RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Incidence anti-drug antibodies (ADAs)
Incidence and titer of ADAs against EMB-01 when administered in combination with chemotherapy
Measured: From C1D1 pre-dose until 30 days after last dose, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202631 Dec 2028

First posted16 Jun 2026
Study start30 Sep 2026
Primary completion31 Mar 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Unresectable/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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07649655
Sponsor's protocol ID: EMB01X203
Status last verified: Oct 2026
First submitted: 3 Jun 2026
Last updated: 16 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07649655
Acronym / sponsor ID: EMB01X203
Conditions: Unresectable/Metastatic Colorectal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Sep 2026 (actual)
Primary completion: 31 Mar 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 16 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm A	Experimental	Drug: EMB-01, Drug: IrinotecanEMB-01 + Irinotecan
Arm B	Experimental	Drug: EMB-01, Drug: TAS-102EMB-01 + TAS-102
Arm C	Experimental	Drug: EMB-01, Drug: mFOLFOX6EMB-01 + 5-Flurouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)
Arm D	Experimental	Drug: EMB-01, Drug: FOLFIRIEMB-01 + 5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

1. Male or female patients aged ≥ 18 and < 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.
3. ECOG performance status ≤ 1. 4. Agrees to provide archival tumor tissue (formalin-fixed paraffin-embedded, collected within 18 months) or newly obtained biopsy tissue. If no eligible archival tissue is available and the patient's clinical condition is not suitable for biopsy, the patient may be screened after confirmation and agreement between the investigator and sponsor.
5. Adequate organ function within 14 days prior to the first dose of study treatment 6. Prior anti-tumor therapy:
Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102/fruquintinib/regorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.
Arm C (mFOLFOX6): No prior oxaliplatin-based chemotherapy and no prior anti-EGFR therapy.

Key exclusion criteria (8 listed)

1. Expected survival < 3 months. 2. Presence of KRAS/NRAS (exons 2, 3, 4), BRAF V600, HER2 positivity (IHC3+ and/or amplification), RET/NTRK fusion, or other molecular alterations that may affect anti-EGFR or cMET therapy efficacy, as detected by central laboratory testing at screening or documented in prior treatment history. (Discussion between investigator and sponsor in writing is recommended if applicable.) 3. Persistent adverse events (AEs) from prior anti-tumor therapy > Grade 2 per CTCAE v5.0, except alopecia, Grade 2 fatigue, or Grade 2 peripheral neuropathy.
4. Primary central nervous system (CNS) malignancy or symptomatic CNS/leptomeningeal metastases. Asymptomatic CNS metastases are allowed if no local radiotherapy is required, or if radiotherapy was completed ≥ 4 weeks prior to first study dose.
5. Prior treatment with anti-EGFR × cMET bispecific antibody or bispecific ADC. 6. Discontinuation of EGFR inhibitors due to skin toxicity. 7. History of life-threatening hypersensitivity, or known allergy to recombinant proteins/excipients in EMB-01 or any study treatment contraindication.
8. Systemic corticosteroids (> 10 mg prednisone equivalent/day) or other immunosuppressants required within 14 days prior to first dose, regardless of autoimmune disease. Inhaled/topical/ocular/nasal/joint steroids are permitted; adrenal replacement steroids are allowed at >10 mg/day if no active autoimmune disease.
9. Severe/uncontrolled cardiac disease requiring treatment 10. Use or planned use of QT-prolonging or rhabdomyolysis-inducing drugs during screening through study end (only Arm C); or known CYP3A4/UGT1A1 strong inhibitors/CYP3A4 inducers/anticholinesterase neuromuscular blockers (only Arms A/D).

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-01EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).	Drug	Arm A, Arm B, Arm C, Arm D
IrinotecanIrinotecan will be administered as intravenous infusion.	Drug	Arm A
TAS-102TAS-102 will be administered orally.	Drug	Arm B
mFOLFOX6mFOLFOX6 will be administered as intravenous infusion.	Drug	Arm C
FOLFIRIFOLFIRI will be administered as intravenous infusion.	Drug	Arm D

Primary outcome

Incidence and severity of adverse events (AEs)
Time frame: From enrollment up to 30 days after last dose of study treatment
Safety profile of EMB-01 in combination with chemotherapy will be evaluated by the incidence, severity, seriousness, and relationship of AEs, graded per CTCAE v5.0
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to Cycle 1 (28 days)
DLTs will be assessed according to protocol-defined criteria during the first treatment cycle of EMB-01 in combination with chemotherapy regimens
Tolerability of EMB-01 in combination with chemotherapy
Time frame: From first dose to 30 days after last dose, up to 2 years
Outcome Measure: Treatment interruption due to intolerability and relative dose intensity (RDI)
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2CD)
Time frame: Through study completion, up to 2 years
Determination of the MTD and/or RP2CD of EMB-01 in combination with chemotherapy

9 secondary outcomes

Cmax
Time frame: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Ctrough
Time frame: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Objective response rate (ORR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years.
Disease control rate (DCR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Best Overall Response (BOR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Duration of Response (DOR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Clinical Benefit Rate (CBR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Progression-Free Survival (PFS)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Incidence anti-drug antibodies (ADAs)
Time frame: From C1D1 pre-dose until 30 days after last dose, up to 2 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 16 Oct 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.

Ying Wu contact

86-21-61951000

ywu@epimab.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EMB-01, Irinotecan and TAS-102 in people with Unresectable/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 8 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 16 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Ying Wu (86-21-61951000, ywu@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: From enrollment up to 30 days after last dose of study treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07649655.

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 16 Oct 2026.