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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06341647




Registration number
NCT06341647
Ethics application status
Date submitted
14/03/2024
Date registered
2/04/2024
Date last updated
21/08/2024

Titles & IDs
Public title
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
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
Secondary ID [1] 0 0
103300 (HREC 233/23)
Secondary ID [2] 0 0
AB-201-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]
Timepoint [1] 0 0
up to 18 months per patient
Primary outcome [2] 0 0
Determination of Recommended Phase 2 Dose (RP2D)
Timepoint [2] 0 0
up to 18 months per patient
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
up to 18 months per patient

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2029
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
The Alfred Hosptial - Melbourne
Recruitment hospital [3] 0 0
Austin Hosptial - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GC Cell Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06341647
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
HyeSung Jeon
Address 0 0
Country 0 0
Phone 0 0
+82-31-260-9059
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06341647