CLBR001 + ABBV-461 for Breast Cancer

Recruiting at 1 trial location

Overseen By Alex Brooks

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Calibr, a division of Scripps Research

Must not be taking: Vaccines, T-cell therapy

Disqualifiers: Infection, Cardiovascular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had certain therapies like T-cell cytotoxic therapy within 3 months before joining. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination CLBR001 + ABBV-461 for breast cancer?

Research shows that combining immune therapies, like those targeting PD-1/PD-L1, with other treatments can improve outcomes in breast cancer, especially in certain subtypes like triple-negative breast cancer. These combinations can help the immune system better fight cancer, leading to longer-lasting responses in some patients. ^{1 2 3 4 5}

What makes the treatment CLBR001 + ABBV-461 unique for breast cancer?

The treatment CLBR001 + ABBV-461 is unique because it potentially offers a novel approach for breast cancer, particularly for triple-negative breast cancer (TNBC), which lacks targeted therapies and is typically treated with chemotherapy. This combination may involve innovative mechanisms, such as targeting specific molecular pathways or enhancing immune responses, which are not addressed by standard treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Chan Beals, MD, PhD

Principal Investigator

Calibr-Skaggs Institute for Innovative Medicines

Eligibility Criteria

This trial is for adults over 18 with advanced or metastatic breast cancer that has not responded to standard treatments. Participants must have measurable disease, be in good physical condition (ECOG status 0 or 1), and provide a biopsy sample. They should also have proper blood, kidney, and liver function.

Inclusion Criteria

My breast cancer has returned or didn't respond to treatment.

I have tried all standard treatments available for my condition.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of CLBR001 cells followed by cycles of ABBV-461

4 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• ABBV-461
• CLBR001

Trial Overview The study tests CLBR001 cells combined with ABBV-461 drug cycles on patients with advanced breast cancer. It aims to find the safest and most effective dose while monitoring how well the treatment works and its safety through regular check-ups.

Participant Groups

Group I: Dose Escalation Experimental Treatment 1 Intervention

Combination product CLBR001 + ABBV461 is administered in ascending dose level cohorts to determine the Optimal Biologic Dose (OBD) of CLBR001 + ABBV-461.

Who Is Running the Clinical Trial?

Calibr, a division of Scripps Research

Lead Sponsor

Trials

9

Recruited

400+

Findings from Research

Immune checkpoint blockade (ICB) targeting PD-1 or PD-L1 has shown significant clinical activity in breast cancer, particularly in the triple-negative subtype and in earlier treatment lines, with some patients experiencing durable responses even in metastatic disease.

Current research is focused on enhancing the effectiveness of ICB by converting 'cold' tumors into 'hot' tumors through strategies that improve the tumor microenvironment, expand anti-tumor T cells, and enhance antigen presentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of immune checkpoint blockade in breast cancer. Pellegrino, B., Tommasi, C., Cursio, OE., et al.[2022]

Anti-PD-1 and anti-PD-L1 antibodies show modest response rates as standalone treatments for metastatic breast cancer, but they are generally well tolerated and can provide significant, lasting benefits for some patients.

These antibodies can be safely combined with various systemic therapies, including chemotherapy and targeted therapies, as well as radiotherapy, suggesting potential for enhanced effectiveness in treating metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer. Page, DB., Bear, H., Prabhakaran, S., et al.[2023]

Triple negative breast cancer (TNBC) is a challenging type of breast cancer that does not respond to hormone therapies or HER2-targeted treatments, leading to limited options and poorer survival rates compared to other breast cancer types.

Several targeted therapies, including PARP inhibitors like olaparib and antiangiogenic agents like bevacizumab, are currently being tested in clinical trials, showing promising results that could improve treatment outcomes for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple negative breast cancer: unmet medical needs. Pal, SK., Childs, BH., Pegram, M.[2021]

A novel oncolytic virus-infected cell vaccine (ICV) using a prime-boost strategy showed improved survival in mice with aggressive triple negative breast cancer (TNBC), indicating potential efficacy for this hard-to-treat cancer subtype.

Combining early surgical resection of tumors with the prime-boost vaccination significantly enhanced overall survival and immune memory responses, suggesting a promising therapeutic approach for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterologous prime-boost cellular vaccination induces potent antitumor immunity against triple negative breast cancer. Niavarani, SR., St-Cyr, G., Daniel, L., et al.[2023]

Oncolytic adenoviruses (OAds) represent a promising new therapeutic strategy for treating triple-negative breast cancer (TNBC), which is particularly aggressive and often resistant to standard treatments. Preclinical studies have shown that OAds can selectively target and destroy cancer cells while sparing normal cells, enhancing the potential for improved patient outcomes.

Combining OAds with existing treatments, such as PARP inhibitors like Olaparib and immune checkpoint antibodies, has demonstrated enhanced anti-tumor effects, suggesting that these combinations could lead to more effective therapies for women with TNBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Triple Negative Breast Cancer With Oncolytic Adenoviruses. Green-Tripp, G., Nattress, C., Halldén, G.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A review of immune checkpoint blockade in breast cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy Approaches for Breast Cancer Patients in 2023. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Durvalumab compared to maintenance chemotherapy in metastatic breast cancer: the randomized phase II SAFIR02-BREAST IMMUNO trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Update on the Treatment of Early-Stage Triple-Negative Breast Cancer. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Triple-Negative Breast Cancer: Basic Biology and Immuno-Oncolytic Viruses. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Triple negative breast cancer: unmet medical needs. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Heterologous prime-boost cellular vaccination induces potent antitumor immunity against triple negative breast cancer. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Triple Negative Breast Cancer With Oncolytic Adenoviruses. [2022]