Gastrointestinal CancerPhase 1NCT05411133
Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients
A Phase 1 study testing Cabotamig (ARB202) in people with Gastrointestinal Cancer and Cholangiocarcinoma, run by Arbele Pty Ltd at 3 sites in 2 countries.
Trial summary
This study aims to find out: 1. The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker. 2. To find out how study drug is broken down in the body 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Cholangiocarcinoma, Liver Cancer
- What is being tested?
- Cabotamig (ARB202)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 May 2022to 23 Jul 2025
- Phase
- Phase 1
- 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
- Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients. If the testing is based on fine-needle aspiration (FNA) biopsy, the patient will be considered eligible when tumor aspirate demonstrates detectable positive staining cells for CDH17.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy > 3 months.
- Measurable disease as defined by RECIST 1.1 criteria
- Blood coagulation parameters:
Show all 17Show fewer
- PT INR ≤ 1.5X ULN
- PTT INR ≤1.2X ULN
- Patients must have adequate venous peripheral access for apheresis.
- Satisfactory organ and bone marrow function as defined by:
- absolute neutrophil count > 1,000/μL
- platelets >100,000/μL
- hemoglobin ≥9 g/dL
- serum ALT and AST ≤ 3X ULN or AST and ALT ≤5X ULN, if liver function abnormalities are thought to be from underlying malignancy
- total serum bilirubin ≤ 2X ULN
- Creatinine <1.5X ULN
- Stable amylase for 2 weeks
Who cannot join
- Prior gene therapy or therapy with any murine monoclonal antibodies or any murine containing product.
- Concurrent treatment with any anticancer agent including chemotherapy, hormonal therapy or radiation therapy. Must be 5 X half-life or 6 weeks (whichever is shorter) post dosing of previous cancer therapies.
- History of allergy or hypersensitivity to murine proteins or study product excipients
- Females who are pregnant, trying to become pregnant, or breastfeeding.
- Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV).
- Active infection requiring systemic treatment.
Show all 14Show fewer
- Active brain, leptomeningeal, or paraspinal metastases, except for asymptomatic metastases and are stable on a steroid dose of ≤ 10mg/day of prednisone or its equivalent for at least 14 days prior to the start of study interventions.
- Impaired cardiac function (AHA NY Heart Association Grade II-IV) or clinically significant cardiac disease.
- Lack of recovery of prior CTCAE Grade 3 or above adverse events due to earlier therapies.
- Chronic use of corticosteroids in excess of >10mg daily of prednisone or equivalent within 4 weeks prior to alopecia.
- Concomitant use of complementary or alternative medication or therapy such as Chinese herbal medicine.
- History of Crohn's disease, inflammatory bowel disease, or ulcerative colitis within the past 5 years
- Abnormal bowel function which would make assessment of bowel permeability difficult to access
- Major trauma or major surgery within 4 weeks prior to first dose of study drug
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Southern Oncology Clinical Research Unit
Adelaide
St George Private Hospital
Sydney
About this study
Official title: A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
This study aims to find out:
- The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.
- To find out how study drug is broken down in the body
- To know the effects of the study drug on the tumor.
- Conditions
- Gastrointestinal Cancer, Cholangiocarcinoma, Liver Cancer, Colorectal Adenocarcinoma, Pancreatic Cancer, Gastric Cancer
- Being tested
- Cabotamig (ARB202)
- Medical subject headings
- Gastrointestinal Neoplasms, Cholangiocarcinoma, Liver Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotamig (ARB202)Drug
Cabotamig (ARB202), Atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Not described Receives: Drug: Cabotamig (ARB202) |
| Phase 1b: Low dose Cabotamig (ARB202) | Experimental | Not described Receives: Drug: Cabotamig (ARB202) |
| Phase 1b: High dose Cabotamig (ARB202) | Experimental | Not described Receives: Drug: Cabotamig (ARB202) |
| Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental | Not described Receives: Drug: Cabotamig (ARB202) |
| Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental | Not described Receives: Drug: Cabotamig (ARB202) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: 8 weeks post initial dose
Secondary outcomes (5)
Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients
Measured: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients
Measured: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients
Measured: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients
Measured: 16 weeks
Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 May 2022
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbele Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411133
- Sponsor's protocol ID
- A001
- Status last verified
- Aug 2025
- First submitted
- 25 May 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT05411133
- Acronym / sponsor ID
- A001
- Conditions
- Gastrointestinal Cancer, Cholangiocarcinoma, Liver Cancer, Colorectal Adenocarcinoma, Pancreatic Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Arbele Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 9 Jun 2022 (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 aims to find out:
- The tolerability of Cabotamig (ARB202) in adults with advanced solid gastrointestinal tumors who failed the standard treatment. People can participate if their tumor has the CDH17 marker.
- To find out how study drug is broken down in the body
- To know the effects of the study drug on the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Drug: Cabotamig (ARB202) |
| Phase 1b: Low dose Cabotamig (ARB202) | Experimental | Drug: Cabotamig (ARB202) |
| Phase 1b: High dose Cabotamig (ARB202) | Experimental | Drug: Cabotamig (ARB202) |
| Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental | Drug: Cabotamig (ARB202) |
| Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor | Experimental | Drug: Cabotamig (ARB202) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed colorectal, pancreatic, gastric adenocarcinoma, primary liver cancer or metastatic liver disease, or cholangiocarcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Malignancies should possess with ≥10% expression of CDH17 confirmed by immunohistochemistry except for CRC patients. If the testing is based on fine-needle aspiration (FNA) biopsy, the patient will be considered eligible when tumor aspirate demonstrates detectable positive staining cells for CDH17.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy > 3 months.
- Measurable disease as defined by RECIST 1.1 criteria
Key exclusion criteria (14 listed)
- Prior gene therapy or therapy with any murine monoclonal antibodies or any murine containing product.
- Concurrent treatment with any anticancer agent including chemotherapy, hormonal therapy or radiation therapy. Must be 5 X half-life or 6 weeks (whichever is shorter) post dosing of previous cancer therapies.
- History of allergy or hypersensitivity to murine proteins or study product excipients
- Females who are pregnant, trying to become pregnant, or breastfeeding.
- Diagnosis of HIV or chronic active viral hepatitis (HBV, HCV, HIV).
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 |
|---|---|---|
| Cabotamig (ARB202)Cabotamig (ARB202), Atezolizumab | Drug | Phase 1a: Dose Escalation, Phase 1b: High dose Cabotamig (ARB202), Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor, Phase 1b: Low dose Cabotamig (ARB202), Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor |
Primary outcome
Incidence and severity of adverse events
Time frame: 8 weeks post initial dose
5 secondary outcomes
Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients
Time frame: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients
Time frame: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients
Time frame: 16 weeks
Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients
Time frame: 16 weeks
Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabotamig (ARB202) in people with Gastrointestinal Cancer and Cholangiocarcinoma, run by Arbele Pty Ltd at 3 sites in 2 countries.
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 17 inclusion and 14 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: finished, as of the sponsor's last update on 19 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 3 sites in Australia, Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (time frame: 8 weeks post initial dose). 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 19 Mar 2026.