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Trial Title:
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
NCT ID:
NCT05678205
Condition:
Breast Cancer
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AB-201
Description:
NK Cell Therapy
Arm group label:
Phase 1 Dose Confirmation
Arm group label:
Phase 2 Cohort A
Arm group label:
Phase 2 Cohort B
Arm group label:
Phase 2 Cohort C
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1 Dose Confirmation
Arm group label:
Phase 2 Cohort A
Arm group label:
Phase 2 Cohort B
Arm group label:
Phase 2 Cohort C
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Lymphodepleting chemotherapy
Arm group label:
Phase 1 Dose Confirmation
Arm group label:
Phase 2 Cohort A
Arm group label:
Phase 2 Cohort B
Arm group label:
Phase 2 Cohort C
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Oregon Health Science University (OHSU)
Address:
City:
Portland
Zip:
97239
Country:
United States
Contact:
Last name:
Yazan Migdady, MD
Investigator:
Last name:
Yazan Migdady, MD
Email:
Principal Investigator
Facility:
Name:
The Catholic University of Korea, St. Vincent's Hospital
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Contact:
Last name:
Byoung Y Shim, MD
Investigator:
Last name:
Byoung Y Shim, MD
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
April 2027
Lead sponsor:
Agency:
Artiva Biotherapeutics, Inc.
Agency class:
Industry
Source:
Artiva Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678205
