Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 (NCT06341647) | Clinical Trial Compass
WithdrawnPhase 1
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
Stopped: Determined that enrollment would be limited due to the change in care setting.
0Started 2024-10-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]