Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341647
• Other study ID #: AB-201-01
• Secondary ID: 103300 (HREC 233
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 31, 2024
• Est. completion date: February 2029

Study information

• Verified date: March 2024
• Source: GC Cell Corporation
• Contact: HyeSung Jeon
• Phone: +82-31-260-9059
• Email: hs_jeon[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and gastric/GEJ cancers).

The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by a dose expansion stage.

Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 2029
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
• AB-201
NK Cell Therapy
• Cyclophosphamide
Lymphodepleting chemotherapy
• Fludarabine
Lymphodepleting chemotherapy

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	The Alfred Hosptial	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]	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.	up to 18 months per patient
Primary	Determination of Recommended Phase 2 Dose (RP2D)	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.	up to 18 months per patient
Secondary	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	The proportion of subjects who experienced an PR or CR, as assessed by investigators per RECIST v1.1.	up to 18 months per patient