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

Primary Purpose

Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AB-201
Cyclophosphamide
Fludarabine
Sponsored by
Artiva Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Oregon Health Science University (OHSU)
  • The Catholic University of Korea, St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1 Dose Confirmation

Phase 2 Cohort A

Phase 2 Cohort B

Phase 2 Cohort C

Arm Description

Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression

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

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

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

Outcomes

Primary Outcome Measures

Safety: incidence and severity of adverse events and serious adverse events
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

Secondary Outcome Measures

Full Information

First Posted
December 23, 2022
Last Updated
May 2, 2023
Sponsor
Artiva Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05678205
Brief Title
A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Artiva Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Subjects will receive up to 3 doses of AB-201, followed by scheduled assessments of overall health and tumor response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Dose Confirmation
Arm Type
Experimental
Arm Description
Dose Confirmation of AB-201 in advanced metastatic breast cancer, gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression
Arm Title
Phase 2 Cohort A
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 2 Cohort B
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 2 Cohort C
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AB-201
Intervention Description
NK Cell Therapy
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lymphodepleting chemotherapy
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lymphodepleting chemotherapy
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AB-201-01 Study Team
Phone
858-267-4465
Email
AB-201-01StudyTeam@ArtivaBio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorsten Graef, MD, Ph.D
Organizational Affiliation
Artiva Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yazan Migdady, MD
First Name & Middle Initial & Last Name & Degree
Yazan Migdady, MD
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoung Y Shim, MD
First Name & Middle Initial & Last Name & Degree
Byoung Y Shim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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