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A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors

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NCT05678205 · readout ≤ 253 d

Sponsored by Artiva Biotherapeutics, Inc. (industry) · ARTV — their whole pipeline →.

Phase
Phase 1/2
Status
Withdrawn
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
0actual
Sites
2
Countries
South Korea, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Corporate business decision

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-08-01estimatedWhen the study began enrolling
Primary completionApr 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionApr 2027estimatedThe whole study's end, after follow-up
First posted2023-01-10actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-07-30actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Breast Cancer
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Interventions

  • Drug: AB-201
  • Drug: Cyclophosphamide
  • Drug: Fludarabine

Primary outcomes

what the primary-completion date above is the date OF
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)

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