NCT05411133

Brief Summary

This study aims to find out:

  1. 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. 2.To find out how study drug is broken down in the body
  3. 3.To know the effects of the study drug on the tumor.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

March 19, 2026

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

May 25, 2022

Last Update Submit

March 17, 2026

Conditions

Gastrointestinal CancerLiver CancerGastrointestinal Neuroendocrine TumorsCholangiocarcinomaColorectal AdenocarcinomaPancreatic CancerGastric CancerEsophageal AdenocarcinomaGastroesophageal Junction

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events

    8 weeks post initial dose

Secondary Outcomes (5)

  • Amount of Cabotamig (ARB202) in plasma after single and multiple doses of ARB202 (Cabotamig) in patients

    16 weeks

  • Biochemical and physiological effects of Cabotamig (ARB202) on the amount of circulating ARB202 (Cabotamig) level in patients

    16 weeks

  • Biochemical and physiological effects of Cabotamig (ARB202) on the amount of soluble CDH17 level in patients

    16 weeks

  • Biochemical and physiological effects of Cabotamig (ARB202) on the amount IL-2 level in patients

    16 weeks

  • Effect of Cabotamig (ARB202) on tumour as determined by changes in RECIST evaluation from baseline

    6 weeks

Study Arms (5)

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)

Interventions

Cabotamig (ARB202)DRUG

Cabotamig (ARB202), Atezolizumab

Phase 1a: Dose EscalationPhase 1b: High dose Cabotamig (ARB202)Phase 1b: High dose Cabotamig (ARB202) + Immune Checkpoint InhibitorPhase 1b: Low dose Cabotamig (ARB202)Phase 1b: Low dose Cabotamig (ARB202) + Immune Checkpoint Inhibitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southern Oncology Clinical Research Unit

Adelaide, Australia

Location

St George Private Hospital

Sydney, Australia

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsCholangiocarcinomaLiver NeoplasmsPancreatic NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 9, 2022

Study Start

May 30, 2022

Primary Completion

July 23, 2025

Study Completion

July 23, 2025

Last Updated

March 19, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)HK(1)