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

NCT06341647 | Withdrawn Phase 1

• 2 other identifiers: AB-201-01103300 (HREC 233/23)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

  up to 18 months per patient

Study Arms (2)

Phase 1a Dose Escalation

EXPERIMENTAL

* 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; Drug: Cyclophosphamide; Drug: Fludarabine

Phase 1b Dose Expansion

EXPERIMENTAL

* 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; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

AB-201 DRUG

NK Cell Therapy

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Fludarabine DRUG

Lymphodepleting chemotherapy

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GC Cell Corporation: lead

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Safety: incidence and severity of AE and SAE \[Time Frame: From the time of consent through End of Study (up to 18 months per patient)\] * Determination of Recommended Phase 2 Dose (RP2D)

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share