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Oncology Clinical Trial Finder
Breast Cancer
Location

Terminated • Phase I • Stage III, IV • PR negative • HER2 negative • Medical Oncology • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

ATRC-101-A01 is a Phase 1b, open-label dose escalation and expansion trial of ATRC-101, an engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101 will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a monotherapy or in combination with other anticancer agents.

For the monotherapy cohorts, including the efficacy expansion cohorts, enrollment is restricted to adults with inoperable, locally advanced or metastatic breast cancer, NSCLC, CRC, ovarian cancer, and acral melanoma, which are all tumor types that have demonstrated ATRC-101 immunoreactivity on at least 50% of tested commercially procured archival specimens. For the pembrolizumab combination therapy cohort, enrollment is restricted to adults with inoperable, locally advanced or metastatic NSCLC, CRC (only MSI-H or dMMR), melanoma (with the exception of uveal melanoma), HCC, HNSCC, ESCC, UC or TNBC, that have been treated with anti-PD-1 or anti-PD-L1 therapy and have progressed radiographically or have achieved stable disease for a minimum of two months and who, in the judgment of their treating physicians, could benefit from a combination of ATRC 101 and pembrolizumab. For the PLD combination therapy cohort, enrollment is restricted to adult females with inoperable, locally advanced or metastatic high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum resistant, defined as progression during or within 6 months of the last dose of platinum-based chemotherapy OR breast cancer that is refractory to other standard therapies. For target-enriched expansion cohorts, enrollment will be limited to participants with pretreatment tumor biopsies demonstrating ATRC-101 target expression above a predefined threshold by IHC at a central laboratory.

Breast Cancer

Study Design
Study type:

Interventional

Estimated enrollment:

87 participant

Actual study start date:

February 11, 2020

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:

both


Arms and Intervention
  • ATRC-101

  • Pembrolizumab

  • Pegylated liposomal doxorubicin (PLD)

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:

Terminated

Estimated Enrollment:

87

Last Updated:

01/01/2024


Principal Investigator

Sudha Khurana, PhD


Trial Sponsor

Atreca, Inc.

Study Location (22)

Mayo Clinic

Rochester, Minnesota, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Oncology Specialists of Charlotte

Charlotte, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

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