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Monoclonal Antibodies
AB-201 for Advanced HER2+ Breast Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Artiva Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of consent through end of study (up to 18 months per patient)
Awards & highlights
Study Summary
This trial evaluates a drug's safety and effectiveness in people with advanced HER2+ solid tumors. Subjects receive up to 3 doses, with assessments of health and tumor response.
Who is the study for?
This trial is for adults with advanced HER2+ breast or gastric/GEJ cancer who've had prior treatments but their disease didn't respond or they couldn't tolerate the treatment. They should be relatively healthy (ECOG 0-1) and not have other cancers, serious heart issues, active brain metastases, or severe health decline recently.Check my eligibility
What is being tested?
The trial tests AB-201's safety and tumor-fighting ability in two phases. Phase 1 checks how safe it is for people with advanced HER2+ tumors; Phase 2 looks at how well it works. Participants will get up to three doses of AB-201 along with assessments of their health and tumor response.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion of AB-201, as well as those associated with cyclophosphamide and fludarabine like nausea, hair loss, mouth sores, diarrhea, low blood cell counts increasing infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of consent through end of study (up to 18 months per patient)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of consent through end of study (up to 18 months per patient)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Efficacy: Objective Response Rate, defined as the proportion of patients with a complete or partial response
Safety: incidence and severity of adverse events and serious adverse events
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort CExperimental Treatment3 Interventions
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
Group II: Phase 2 Cohort BExperimental Treatment3 Interventions
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
Group III: Phase 2 Cohort AExperimental Treatment3 Interventions
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
Group IV: Phase 1 Dose ConfirmationExperimental Treatment3 Interventions
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
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Who is running the clinical trial?
Artiva Biotherapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
280 Total Patients Enrolled
Thorsten Graef, MD, Ph.DStudy DirectorArtiva Biotherapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had cancer types other than the one I'm seeking treatment for.I have a known heart condition.I still have side effects from previous cancer treatments.My brain metastases have been stable for at least 3 months.I am currently fighting an infection that needs strong medication.I am fully active or can carry out light work.My health has significantly worsened in the last 2 weeks before starting lymphodepletion.My cancer is HER2 positive, confirmed by a test within the last 6 months.My HER2+ cancer cannot be surgically removed and does not respond to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Confirmation
- Group 2: Phase 2 Cohort A
- Group 3: Phase 2 Cohort B
- Group 4: Phase 2 Cohort C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must a person meet to qualify for this clinical trial?
"In order to be accepted as a trial participant, prospective patients must have been diagnosed with breast cancer and meet the age criteria of 18-99. This clinical study is currently seeking 133 volunteers in total."
Answered by AI
Is the enrollment age limit for this study inclusive of those over thirty?
"According to the inclusion criteria for this medical study, those who meet its requirements are aged 18-99. However, there is a separate clinical trial specifically for those under 18 and another one dedicated to adults over 65 with 2344 participants already enrolled."
Answered by AI
Are individuals being accepted for enrollment in this trial?
"Clinicaltrials.gov data indicates that this trial, which was first posted on March 1st 2023 and last updated two months ago, is no longer actively recruiting participants. However, a multitude of other studies with open enrolment are currently available in the same field."
Answered by AI
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