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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06341647
Registration number
NCT06341647
Ethics application status
Date submitted
14/03/2024
Date registered
2/04/2024
Date last updated
2/04/2024
Titles & IDs
Public title
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
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Scientific title
A Multicenter, Open-label, Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced Human Epidermal Growth Factor Receptor 2 Positive(HER2+) Solid Tumors
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Secondary ID [1]
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103300 (HREC 233/23)
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Secondary ID [2]
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AB-201-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Gastric Cancer
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Gastroesophageal Junction Adenocarcinoma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AB-201
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Experimental: Phase 1a Dose Escalation - Dose Escalation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Interventions:
Drug: AB-201
Drug: Cyclophosphamide
Drug: Fludarabine
Experimental: Phase 1b Dose Expansion - Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Interventions:
Drug: AB-201
Drug: Cyclophosphamide
Drug: Fludarabine
Treatment: Drugs: AB-201
NK Cell Therapy
Treatment: Drugs: Cyclophosphamide
Lymphodepleting chemotherapy
Treatment: Drugs: Fludarabine
Lymphodepleting chemotherapy
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]
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Assessment method [1]
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Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
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Timepoint [1]
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up to 18 months per patient
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Primary outcome [2]
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Determination of Recommended Phase 2 Dose (RP2D)
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Assessment method [2]
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Assessment of Dose-Limiting Toxicities(DLTs), pharmacokinetics (PK), safety, and objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 in subjects with HER2+ breast cancer and gastric/GEJ cancer.
PK: Monitor persistence of AB-201 in subjects samples collected prior to and following AB-201 administration.
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Timepoint [2]
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up to 18 months per patient
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Secondary outcome [1]
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To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors
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Assessment method [1]
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The proportion of subjects who experienced an PR or CR, as assessed by investigators per RECIST v1.1.
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Timepoint [1]
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up to 18 months per patient
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Eligibility
Key inclusion criteria
- ECOG performance status 0 to 1.
- Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC = 2+ within 6
months prior to study entry.
- Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or
gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or for
which no standard treatment is available.
- Must have received prior cancer therapy: Subjects with breast cancer must have
received = 3 prior systemic therapies; subjects with gastric/GEJ cancer must have
received = 2 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+ cancers
must have received previous treatment with a HER2-targeting therapy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known past or current malignancy other than inclusion diagnosis.
- Known clinically significant cardiac disease.
- Active central nervous system (CNS) metastases, or involvement of the CNS, unless
there is a history of at least 3 months of sustained remission.
- Unresolved toxicities from prior anticancer therapy.
- Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or
anti-viral therapy.
- History of sensitivity or intolerance to cyclophosphamide or fludarabine.
- Currently Pregnant or lactating
- Severe disease progression or health deterioration within 2 weeks prior to
lymphodepletion regimen.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2029
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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The Alfred Hosptial - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GC Cell Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two
phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the
safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06341647
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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HyeSung Jeon
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Address
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Country
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Phone
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+82-31-260-9059
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06341647
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