Breast CancerPhase 1NCT06341647
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
A Phase 1 study testing AB-201, Cyclophosphamide and Fludarabine in people with Breast Cancer and Gastric Cancer, run by GC Cell Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- No sites listed yet
- Study dates
- 31 Oct 2024to Feb 2029
- Phase
- Phase 1
- 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 years and older
- 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 ≥ 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.
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.
- Currently Pregnant or lactating
- Severe disease progression or health deterioration within 2 weeks prior to lymphodepletion regimen.
About this study
Official title: A Multicenter, Open-label, Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced Human Epidermal Growth Factor Receptor 2 Positive(HER2+) Solid Tumors
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.
Read the detailed description
This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and gastric/GEJ cancers).
The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by a dose expansion stage.
Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201.
- 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 1a Dose Escalation | Experimental | * Dose Escalation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
* Interventions:
* Drug: AB-201
* Drug: Cyclophosphamide
* Drug: Fludarabine Receives: Drug: AB-201; Drug: Cyclophosphamide; Drug: Fludarabine |
| Phase 1b Dose Expansion | Experimental | * Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
* Interventions:
* Drug: AB-201
* Drug: Cyclophosphamide
* Drug: Fludarabine 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.
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]
Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: up to 18 months per patient
Determination of Recommended Phase 2 Dose (RP2D)
Assessment of Dose-Limiting Toxicities(DLTs), pharmacokinetics (PK), safety, and objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 in subjects with HER2+ breast cancer and gastric/GEJ cancer.
PK: Monitor persistence of AB-201 in subjects samples collected prior to and following AB-201 administration.
Measured: up to 18 months per patient
Secondary outcomes (1)
To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors
The proportion of subjects who experienced an PR or CR, as assessed by investigators per RECIST v1.1.
Measured: 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 posted2 Apr 2024
- Study start31 Oct 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionFeb 2029 (estimated)
Why it stopped: Determined that enrollment would be limited due to the change in care setting.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- * Safety: incidence and severity of AE and SAE \[Time Frame: From the time of consent through End of Study (up to 18 months per patient)\] * Determination of Recommended Phase 2 Dose (RP2D)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341647
- Sponsor's protocol ID
- AB-201-01
- Other IDs
- 103300 (HREC 233/23)
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced Human Epidermal Growth Factor Receptor 2 Positive(HER2+) Solid Tumors
- ClinicalTrials.gov ID
- NCT06341647
- Acronym / sponsor ID
- AB-201-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Determined that enrollment would be limited due to the change in care setting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 2 Apr 2024 (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, 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.
Detailed description
This is a Phase 1, multicenter study designed to evaluate the safety, tolerability, and efficacy of AB-201 in subjects with advanced HER2+ solid tumors (specifically, breast and gastric/GEJ cancers).
The Phase 1 will be conducted in two parts, an initial dose escalation stage followed by a dose expansion stage.
Study participation for each subject begins with up to 28 days (1 month) of screening following written informed consent, then lymphodepletion treatment, followed by AB-201. Up to 3 doses of AB-201 may be administered. All subjects will be monitored for a total duration of 18 months of follow up from the first dose administration of AB-201.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Safety: incidence and severity of AE and SAE [Time Frame: From the time of consent through End of Study (up to 18 months per patient)] * Determination of Recommended Phase 2 Dose (RP2D)
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: Fludarabine* Dose Escalation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression * Interventions: * Drug: AB-201 * Drug: Cyclophosphamide * Drug: Fludarabine |
| Phase 1b Dose Expansion | Experimental | Drug: AB-201, Drug: Cyclophosphamide, Drug: Fludarabine* Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression * Interventions: * Drug: AB-201 * Drug: Cyclophosphamide * Drug: Fludarabine |
Who may qualify
- Ages
- 18 years and older
- 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 ≥ 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.
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 1a Dose Escalation, Phase 1b Dose Expansion |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability]
Time frame: up to 18 months per patient
Adverse events and laboratory abnormalities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Determination of Recommended Phase 2 Dose (RP2D)
Time frame: up to 18 months per patient
Assessment of Dose-Limiting Toxicities(DLTs), pharmacokinetics (PK), safety, and objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 in subjects with HER2+ breast cancer and gastric/GEJ cancer. PK: Monitor persistence of AB-201 in subjects samples collected prior to and following AB-201 administration.
1 secondary outcome
To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors
Time frame: 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 24 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-201, Cyclophosphamide and Fludarabine in people with Breast Cancer and Gastric Cancer, run by GC Cell Corporation.
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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability] (time frame: up to 18 months per patient). The study lists 2 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 24 Jan 2025.