OncRef

Clinical Trial: NCT06878248

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

Status:

TERMINATED

Phase:

Phase 1

Lead Sponsor:Calibr, a division of Scripps Research
Information Provided By:Calibr, a division of Scripps Research
Last Update Posted:2026-05-28

Study Overview

Brief Summary

The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses.

Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.

Official Title

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, an Engineered Autologous T Cell Product, and ABBV-461, an Antibody-Based Biologic, in Subjects With Locally Advanced or Metastatic Breast Cancer

Conditions

Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC), Hormone Receptor-Positive Breast Cancer, HER2 + Breast Cancer

Intervention / Treatment

  • Biological: Two Component Product CLBR001 + ABBV-461

Other Study ID Numbers

  • CBR-sCAR461-3001

Start Date (Actual)

2025-04-17

Primary Completion Date (Actual)

2026-04-09

Study Completion Date (Actual)

2026-04-09

Enrollment (Actual)

10

Study Type

Interventional

Phase

Phase 1