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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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Contact person for scientific queries



Summary Results

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