A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
Phase 1
Not yet recruiting
- Conditions
- Breast CancerGastric CancerGastroesophageal Junction Adenocarcinoma
- Interventions
- Registration Number
- NCT05678205
- Lead Sponsor
- Artiva Biotherapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 133
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 ≥ 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 Dose Confirmation AB-201 Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression Phase 1 Dose Confirmation Fludarabine Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression Phase 2 Cohort A AB-201 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 Phase 2 Cohort A Cyclophosphamide 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 Phase 2 Cohort B AB-201 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 Phase 2 Cohort C Cyclophosphamide 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 Phase 1 Dose Confirmation Cyclophosphamide Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression Phase 2 Cohort A Fludarabine 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 Phase 2 Cohort C AB-201 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 Phase 2 Cohort B Cyclophosphamide 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 Phase 2 Cohort B Fludarabine 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 Phase 2 Cohort C Fludarabine 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
- Primary Outcome Measures
Name Time Method Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response 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 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 From the time of consent through End of Study (up to 18 months per patient)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Oregon Health Science University (OHSU)
🇺🇸Portland, Oregon, United States
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of