Metastatic Colorectal CancerPhase 1/2NCT05167448
A Study of ES104 in Patients With Metastatic Colorectal Cancer
A Phase 1/2 study testing ES104 in people with Metastatic Colorectal Cancer, run by Elpiscience (Suzhou) Biopharma, Ltd. at 1 site in China.
Trial summary
The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies. 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?
- ES104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to 24 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Ability to understand and the willingness to sign a written informed consent form.
- Locally advanced or metastatic colorectal adenocarcinoma confirmed by pathology and not surgically resectable, having received systemic therapy and failed.
- At least one measurable lesion is required (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
- Adequate organ function, as assessed by the results of the laboratory tests specified in the protocol.
- Male and female subjects of childbearing potential must be willing to use effective contraceptive methods, from the time of signing informed consent and for the duration of study participation through 180 days following the last dose of study drug.
Who cannot join
- Receipt of any systemic antitumor therapy within 28 days prior to the first dose of study drug.
- Known history of severe allergy to any monoclonal antibody or study drug excipient.
- The subject has received or is receiving treatment in another clinical trial within 28 days prior to the first dose of study drug (except for participation in the overall survival follow-up of a study)
- Receipt of antiplatelet agents or anticoagulants for therapeutic purposes within 14 days prior to the first dose of study drug.
- Receipt of live vaccination within 28 days prior to the first dose of study drug.
- Prior history of allogeneic organ transplantation or allogeneic peripheral blood stem cell (PBSC)/bone marrow transplantation treatment.
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- Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before the first dose of study drug. Certain exceptions as defined in protocol apply.
- Subjects with active metastatic brain or meningeal metastases.
- Patients with other primary malignancies within 5 years before the first dose of study drug. Some exceptions as defined per protocol apply.
- Major surgery or major traumatic injury within 28 days prior to the first dose of study drug (in the judgment of the Investigator).
- History of cardiovascular disease as defined by the protocol within the past 5 years.
- History of bleeding-related illness as defined by the protocol.
- Presence of severe, unhealed or open wounds and active ulcers or untreated fractures.
- Known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome.
- Chronic active hepatitis B or active hepatitis C.
- Active infection requiring systemic therapy 14 days prior to first dose of study drug.
- Pregnant or nursing females.
- Known history of alcohol or drug abuse.
- Subjects with comorbidities or other conditions that may affect compliance with the protocol or are not suitable for participation in this study in the judgment of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Clinical Trial of ES104 in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer Who Have Failed Systemic Therapies
The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- ES104
- Keywords
- ES104
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES104Drug
ES104 is administered via Intravenous infusion, at dose of 10 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
ES104Drug
ES104 is administered via Intravenous infusion, at dose of 12.5 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
ES104Drug
ES104 is administered via Intravenous infusion, at dose of RP2D, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Phase 1 | Experimental | Not described Receives: Drug: ES104 |
| Cohort 2 Phase 1 | Experimental | Not described Receives: Drug: ES104 |
| RP2D Phase 2 | Experimental | Not described Receives: Drug: ES104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: The frequency and severity of adverse events of ES104
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 1-3 years
Phase 2: The anti-tumor activity of ES104
The Objective Remission Rate (ORR) will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Measured: 2-5 years
Secondary outcomes (10)
Phase 1: Maximum observed serum concentration (Cmax) of ES104
Maximum observed serum concentration (Cmax) of ES104 will be measured.
Measured: 1-3 years
Phase 1:Time to Cmax (Tmax) of ES104
Time to Cmax (Tmax) of ES104 will be measured.
Measured: 1-3 years
Phase 1:Area under the serum concentration time curve (AUC) of ES104
Area under the serum concentration time curve (AUC) of ES104 will be measured.
Measured: 1-3 years
Phase 1:The clearance of ES104
A pharmacokinetic measurement of the volume of plasma from which ES104 is completely removed per unit time.
Measured: 1-3 years
Phase 1: The immunogenicity of ES104
The presence and the frequency of anti-drug antibodies (ADA) against ES104 will be measured.
Measured: 1-3 years
Phase 1: The preliminary anti-tumor activity of ES104
Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Measured: 1-3 years
Phase 2: The anti-tumor activity of ES104
Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
Measured: 2-5 years
Phase 2: The frequency and severity of adverse events of ES104
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: 2-5 years
Phase 2: The popPK profile of ES104
The Cmin,ss、CL and Vd of ES104 will be measured.
Measured: 2-5 years
Phase 2: The immunogenicity of ES104
The presence and the frequency of anti-drug antibodies (ADA) against ES104 will be measured.
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start25 Feb 2022
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Why it stopped: Sponsor's development strategy adjustment.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpiscience (Suzhou) Biopharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167448
- Sponsor's protocol ID
- ES104-1001
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2021
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of ES104 in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer Who Have Failed Systemic Therapies
- ClinicalTrials.gov ID
- NCT05167448
- Acronym / sponsor ID
- ES104-1001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- ES104
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's development strategy adjustment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Elpiscience (Suzhou) Biopharma, Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 22 Dec 2021 (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 purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Phase 1 | Experimental | Drug: ES104 |
| Cohort 2 Phase 1 | Experimental | Drug: ES104 |
| RP2D Phase 2 | Experimental | Drug: ES104 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and the willingness to sign a written informed consent form.
- Locally advanced or metastatic colorectal adenocarcinoma confirmed by pathology and not surgically resectable, having received systemic therapy and failed.
- At least one measurable lesion is required (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
Key exclusion criteria (19 listed)
- Receipt of any systemic antitumor therapy within 28 days prior to the first dose of study drug.
- Known history of severe allergy to any monoclonal antibody or study drug excipient.
- The subject has received or is receiving treatment in another clinical trial within 28 days prior to the first dose of study drug (except for participation in the overall survival follow-up of a study)
- Receipt of antiplatelet agents or anticoagulants for therapeutic purposes within 14 days prior to the first dose of study drug.
- Receipt of live vaccination within 28 days prior to the first dose of study drug.
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 |
|---|---|---|
| ES104ES104 is administered via Intravenous infusion, at dose of 10 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years. | Drug | Cohort 1 Phase 1 |
| ES104ES104 is administered via Intravenous infusion, at dose of 12.5 mg/kg, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years. | Drug | Cohort 2 Phase 1 |
| ES104ES104 is administered via Intravenous infusion, at dose of RP2D, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years. | Drug | RP2D Phase 2 |
Primary outcome
Phase 1: The frequency and severity of adverse events of ES104
Time frame: 1-3 years
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Phase 2: The anti-tumor activity of ES104
Time frame: 2-5 years
The Objective Remission Rate (ORR) will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
10 secondary outcomes
Phase 1: Maximum observed serum concentration (Cmax) of ES104
Time frame: 1-3 years
Phase 1:Time to Cmax (Tmax) of ES104
Time frame: 1-3 years
Phase 1:Area under the serum concentration time curve (AUC) of ES104
Time frame: 1-3 years
Phase 1:The clearance of ES104
Time frame: 1-3 years
Phase 1: The immunogenicity of ES104
Time frame: 1-3 years
Phase 1: The preliminary anti-tumor activity of ES104
Time frame: 1-3 years
Phase 2: The anti-tumor activity of ES104
Time frame: 2-5 years
Phase 2: The frequency and severity of adverse events of ES104
Time frame: 2-5 years
Phase 2: The popPK profile of ES104
Time frame: 2-5 years
Phase 2: The immunogenicity of ES104
Time frame: 2-5 years
Results and safety
The study was stopped early (reason given: Sponsor's development strategy adjustment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ES104 in people with Metastatic Colorectal Cancer, run by Elpiscience (Suzhou) Biopharma, Ltd. at 1 site 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 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 1 site 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 combined 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.
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?
The study was stopped early (reason given: Sponsor's development strategy adjustment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: The frequency and severity of adverse events of ES104 (time frame: 1-3 years). 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 26 Oct 2026.