RecruitingPhase 1NCT06878248

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

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

Sponsor

Calibr, a division of Scripps Research

Enrollment

20 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Locally Advanced Breast Cancer (LABC)Malignant Neoplasm of Breast

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination of two experimental drugs — CLBR001 and ABBV-461 — for people with advanced breast cancer that has stopped responding to all available standard treatments. Researchers want to understand if this combination is safe and if it can shrink tumors. **You may be eligible if:** - You have locally advanced or metastatic breast cancer that has returned or stopped responding to treatment - You have tried all standard treatment options available to you - Your cancer can be measured on a scan - You are 18 or older (men or women) - You are in reasonably good physical health (ECOG performance status 0–1) **You may NOT be eligible if:** - You have not yet exhausted standard treatment options - Your cancer cannot be measured on imaging - You have serious health conditions that could make participation unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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