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

Phase 1

Not yet recruiting

• Conditions: Breast Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

• Registration Number: NCT06341647
• Lead Sponsor: GC Cell Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - ECOG performance status 0 to 1.<br><br> - Histologically confirmed HER2 expressed breast or gastric/GEJ cancer IHC = 2+ within<br> 6 months prior to study entry.<br><br> - Confirmed diagnosis of an advanced/unresectable or metastatic HER2+ breast or<br> gastric/GEJ cancer that is refractory to, or intolerable of standard treatment, or<br> for which no standard treatment is available.<br><br> - Must have received prior cancer therapy: Subjects with breast cancer must have<br> received = 3 prior systemic therapies; subjects with gastric/GEJ cancer must have<br> received = 2 prior systemic therapy(ies); subjects with IHC 3+ or IHC 2+/ISH+<br> cancers must have received previous treatment with a HER2-targeting therapy.<br><br>Exclusion Criteria:<br><br> - Known past or current malignancy other than inclusion diagnosis.<br><br> - Known clinically significant cardiac disease.<br><br> - Active central nervous system (CNS) metastases, or involvement of the CNS, unless<br> there is a history of at least 3 months of sustained remission.<br><br> - Unresolved toxicities from prior anticancer therapy.<br><br> - Ongoing uncontrolled systemic infections requiring antibiotic, anti-fungal, or<br> anti-viral therapy.<br><br> - History of sensitivity or intolerance to cyclophosphamide or fludarabine.<br><br> - Currently Pregnant or lactating<br><br> - Severe disease progression or health deterioration within 2 weeks prior to<br> lymphodepletion regimen.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability];Determination of Recommended Phase 2 Dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
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