Treatment of Cabotamig (ARB202) in Advanced Gastrointestinal Cancer Patients
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ClinicalTrials.gov Identifier: NCT05411133 |
Recruitment Status :
Recruiting
First Posted : June 9, 2022
Last Update Posted : January 23, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Cancer Cholangiocarcinoma Liver Cancer Colorectal Adenocarcinoma Pancreatic Cancer Gastric Cancer Esophageal Adenocarcinoma Gastroesophageal Junction | Drug: Cabotamig (ARB202) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 68 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, First-in-human Study of Cabotamig (ARB202), Bispecific Antibody to CDH17 and CD3 in Advanced Gastrointestinal Malignancies |
Actual Study Start Date : | May 30, 2022 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | August 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Phase 1a: Dose Escalation |
Drug: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab |
Experimental: Phase 1b: Low dose Cabotamig (ARB202) |
Drug: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab |
Experimental: Phase 1b: High dose Cabotamig (ARB202) |
Drug: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab |
Experimental: Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor |
Drug: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab |
Experimental: Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor |
Drug: Cabotamig (ARB202)
Cabotamig (ARB202), Atezolizumab |
- Incidence and severity of adverse events [ Time Frame: 8 weeks post initial dose ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Life expectancy > 3 months.
- Measurable disease as defined by RECIST 1.1 criteria
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Blood coagulation parameters:
- PT INR ≤ 1.5X ULN
- PTT INR ≤1.2X ULN
- Patients must have adequate venous peripheral access for apheresis.
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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
Exclusion Criteria:
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411133
Contact: Dennis Wong, M.D | +1 415 632 6596 | dennis.wong@arbelebio.com |
Australia | |
Southern Oncology Clinical Research Unit | Recruiting |
Adelaide, Australia | |
Contact clinicaltrials@socru.org.au | |
St George Private Hospital | Recruiting |
Sydney, Australia | |
Contact: Paul de Souza p.desouza@westernsydney.edu.au | |
Hong Kong | |
Queen Mary Hospital | Recruiting |
Hong Kong, Hong Kong | |
Contact: Roland Leung lcy035@ha.org.hk |
Responsible Party: | Arbele Pty Ltd |
ClinicalTrials.gov Identifier: | NCT05411133 |
Other Study ID Numbers: |
A001 |
First Posted: | June 9, 2022 Key Record Dates |
Last Update Posted: | January 23, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Adenocarcinoma Cholangiocarcinoma Gastrointestinal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |