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

Inclusion Criteria7

Refractory or relapsed locally advanced or metastatic breast cancer
Exhaused all standard of care therapy options
Measurable disease at time of screening in accordance with RECIST v1.1 criteria
Women or men age ≥18 years of age at time of consent
ECOG performance status 0 or 1
Must provide a biopsy sample obtained during the screening period, following the end of the most recent prior line of therapy
Adequate hematological, renal, and liver function

Exclusion Criteria8

History of a clinically significant infection within 4 weeks prior to consent
Active bacterial, viral, and/or fungal infection
Prior allogeneic stem cell transplant
Prior lentiviral- or retroviral-based therapy including CAR-T cell therapy
Prior lymphodepleting or T-cell cytotoxic therapy within 3 months of enrollment
Subjects receiving attenuated vaccines within 4 weeks of consent or need for live vaccine within 12 months of starting study therapy
History of significant cardiovascular conditions within the past 6 months
Subjects with a prior history of or concurrent malignancy whose natural history or treatment has the potential to interfere with either the safety or efficacy assessment of the investigational regimen