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

PHASE1NOT_YET_RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-31

Primary completion: 2027-04-01

Study completion finish: 2029-02-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06341647

Intervention or treatment

DRUG: AB-201

DRUG: Cyclophosphamide

DRUG: Fludarabine

Conditions

• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma

Condition: Breast Cancer, Gastric Cancer and more
DRUG: AB-201 and other drugs
Melbourne, Victoria, Australia and more
Sponsor: GC Cell Corporation

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Peter MacCallum Cancer Centre

Research sites nearby

Select from list below to view details:

Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hosptial
Melbourne, Victoria, Australia
Austin Hosptial
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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	DRUG: AB-201 NK Cell Therapy
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	DRUG: AB-201 NK Cell Therapy

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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