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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

Fludarabine

2012