A Multicenter, Open-label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- AB-201
- Conditions
- Breast Cancer
- Sponsor
- Artiva Biotherapeutics, Inc.
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response
- Status
- Withdrawn
- Last Updated
- 9 months ago
Overview
Brief Summary
This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases. The primary objective of Phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. The primary objective of Phase 2 is to evaluate the efficacy of AB-201.
Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ECOG performance status 0 to
- •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 ≥ 2 prior systemic therapies; subjects with gastric/GEJ cancer must have received ≥ 1 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.
- •Pregnant or lactating females and subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after administration of the last AB-201 dose.
- •Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen.
Arms & Interventions
Phase 1 Dose Confirmation
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Intervention: AB-201
Phase 1 Dose Confirmation
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Intervention: Cyclophosphamide
Phase 1 Dose Confirmation
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Intervention: Fludarabine
Phase 2 Cohort A
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC ≥2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: AB-201
Phase 2 Cohort A
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC ≥2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: Cyclophosphamide
Phase 2 Cohort A
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC ≥2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: Fludarabine
Phase 2 Cohort B
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) that is relapsed to, refractory to, or intolerant of previous trastuzumab deruxtecan (T-DXd) based therapy
Intervention: Cyclophosphamide
Phase 2 Cohort B
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) that is relapsed to, refractory to, or intolerant of previous trastuzumab deruxtecan (T-DXd) based therapy
Intervention: AB-201
Phase 2 Cohort B
AB-201 given to patients with advanced/unresectable or metastatic breast cancer with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) that is relapsed to, refractory to, or intolerant of previous trastuzumab deruxtecan (T-DXd) based therapy
Intervention: Fludarabine
Phase 2 Cohort C
AB-201 given to patients with advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC ≥ 2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: AB-201
Phase 2 Cohort C
AB-201 given to patients with advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC ≥ 2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: Cyclophosphamide
Phase 2 Cohort C
AB-201 given to patients with advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression (IHC ≥ 2+) that is refractory to or intolerant of standard treatment, or for which no standard treatment is available
Intervention: Fludarabine
Outcomes
Primary Outcomes
Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response
Time Frame: From the time of consent through End of Study (up to 18 months per patient)
Safety: incidence and severity of adverse events and serious adverse events
Time Frame: From the time of consent through End of Study (up to 18 months per patient)
Determination of Recommended Phase 2 Dose (RP2D): safety, preliminary efficacy (based on objective response rate (ORR) defined as the proportion of patients with a complete or partial response) and pharmacokinetics
Time Frame: From the time of consent through End of Study (up to 18 months per patient)