Breast CancerPhase 1/2NCT05678205
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
A Phase 1/2 study testing AB-201, Cyclophosphamide and Fludarabine in people with Breast Cancer and Gastric Cancer, run by Artiva Biotherapeutics, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- AB-201, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2023to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Oregon Health Science University (OHSU)
Portland, Oregon, 97239
South Korea1 site
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
About this study
Official title: 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
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.
- Being tested
- AB-201, Cyclophosphamide, Fludarabine
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-201Drug
NK Cell Therapy
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Confirmation | Experimental | Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression Receives: Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine |
| Phase 2 Cohort A | Experimental | 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 Receives: Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine |
| Phase 2 Cohort B | Experimental | 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 Receives: Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine |
| Phase 2 Cohort C | Experimental | 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 Receives: Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence and severity of adverse events and serious adverse events
Measured: 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
Measured: From the time of consent through End of Study (up to 18 months per patient)
Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response
Measured: From the time of consent through End of Study (up to 18 months per patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Aug 2023 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: Corporate business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artiva Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thorsten Graef, MD, Ph.D, Study director, Artiva Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678205
- Sponsor's protocol ID
- AB-201-01
- Status last verified
- Jul 2025
- First submitted
- 23 Dec 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05678205
- Acronym / sponsor ID
- AB-201-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Corporate business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Artiva Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Confirmation | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: FludarabineDose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression |
| Phase 2 Cohort A | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: FludarabineAB-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 | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: FludarabineAB-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 | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: FludarabineAB-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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-201NK Cell Therapy | Drug | Phase 1 Dose Confirmation, Phase 2 Cohort A, Phase 2 Cohort B, Phase 2 Cohort C |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1 Dose Confirmation, Phase 2 Cohort A, Phase 2 Cohort B, Phase 2 Cohort C |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1 Dose Confirmation, Phase 2 Cohort A, Phase 2 Cohort B, Phase 2 Cohort C |
Primary outcome
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Graef, MD, Ph.D study director
Artiva Biotherapeutics
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AB-201, Cyclophosphamide and Fludarabine in people with Breast Cancer and Gastric Cancer, run by Artiva Biotherapeutics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.