ABBV-155 + Taxanes for Solid Cancers

Recruiting at 51 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Untreated brain metastases, Peripheral neuropathy, Active infection, Recent heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

169 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, ABBV-155, alone and with other cancer drugs in patients whose lung or breast cancers have returned or did not respond to previous treatments. ABBV-155 aims to kill cancer cells, while the other drugs help by stopping the cells from growing.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug ABBV-155 + Taxanes for Solid Cancers?

Research shows that taxanes, like nab-paclitaxel (a form of paclitaxel), are effective in treating advanced non-small-cell lung cancer (NSCLC) by improving tumor response and tolerability. This suggests that taxanes could be beneficial in treating other solid cancers as well. ^{1 2 3 4 5}

What safety data exists for ABBV-155 and taxanes in humans?

Taxanes, including forms like nab-paclitaxel (Abraxane), are generally considered safe for treating certain cancers, but they can cause side effects like neurotoxicity (nerve damage) and skin issues. These side effects sometimes require adjusting the dose or stopping treatment to manage them. ^{1 6 7 8 9}

What makes the drug ABBV-155 + Taxanes unique for treating solid cancers?

ABBV-155 combined with taxanes is unique because it potentially offers a novel approach by enhancing the delivery and effectiveness of taxanes, which are already key components in treating various solid tumors. This combination may improve the targeting of cancer cells while reducing side effects compared to traditional taxane treatments. ^{1 7 10 11 12}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with solid tumors that have come back or didn't respond to treatment. It's open to those with specific types of lung and breast cancer, who've tried certain therapies without success. Participants need good organ function, no severe allergies to the drugs being tested, and must not have had serious heart issues or untreated brain metastases recently.

Inclusion Criteria

I have been diagnosed with a solid tumor cancer.

My blood, liver, and kidney tests meet the study's requirements.

My NSCLC has returned or resisted treatment, and I've had targeted therapy if I have specific gene mutations.

Exclusion Criteria

I have side effects from cancer treatment that haven't gone away, except for hair loss.

I do not have an active hepatitis B, C, or HIV infection, or I meet the study's exception criteria.

I do not have severe numbness, pain, or weakness in my hands or feet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ABBV-155 monotherapy or in combination with paclitaxel or docetaxel to determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase Two Dose (RPTD)

Up to approximately 21 days

Dose Expansion

Participants receive ABBV-155 monotherapy or in combination therapy to assess safety, pharmacokinetics, and preliminary efficacy

Up to approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 12 months

Treatment Details

Interventions

• ABBV-155
• Docetaxel
• Paclitaxel

Trial Overview The study tests ABBV-155 alone and combined with taxanes (paclitaxel or docetaxel) in two parts: dose escalation to find safe levels, followed by dose expansion focusing on small cell lung cancer (SCLC) for monotherapy and non-small cell lung cancer (NSCLC)/breast cancer for combination therapy.

Participant Groups

Group I: Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer Experimental Treatment 2 Interventions

Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.

Group II: Expansion 2b: ABBV-155 + docetaxel in NSCLC Experimental Treatment 2 Interventions

Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.

Group III: Expansion 2a: ABBV-155 in SCLC Experimental Treatment 1 Intervention

Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).

Group IV: Escalation 1b: ABBV-155 + paclitaxel or docetaxel Experimental Treatment 3 Interventions

Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .

Group V: Escalation 1a: ABBV-155 Experimental Treatment 1 Intervention

Participants will be administered ABBV-155 (various doses).

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Nab-paclitaxel (Abraxane) has been approved as a first-line treatment for advanced non-small-cell lung cancer (NSCLC) due to its improved antitumor activity and better tolerability compared to traditional solvent-based paclitaxel combined with carboplatin.

Taxanes, including nab-paclitaxel, continue to be a crucial part of the standard care for advanced NSCLC, highlighting their favorable risk-benefit profiles in treating this aggressive cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on taxanes in the first-line treatment of advanced non-small-cell lung cancer. Socinski, MA.[2021]

In a study of 21 patients with recurrent advanced non-small-cell lung cancer (NSCLC), albumin-bound paclitaxel (ABP) monotherapy resulted in a partial response in 28.6% of patients and a disease control rate of 76.2%.

The treatment was generally well tolerated, with manageable side effects, including neutropenia in 11.1% of patients, indicating that ABP can be a viable option for patients who have undergone multiple prior therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of albumin-bound paclitaxel in treating recurrent advanced non-small-cell lung cancer. Xing, PY., Li, JL., Wang, Y., et al.[2021]

In a phase II study involving 37 patients with advanced squamous cell lung cancer (SQCLC), the combination of gemcitabine and albumin-bound paclitaxel (ABP) achieved a high overall response rate (ORR) of 59%, indicating significant antitumor efficacy.

The treatment was found to be safe and well-tolerated, with a median progression-free survival (PFS) of 7.5 months, outperforming traditional carboplatin doublet regimens and showing comparable efficacy to more complex combinations like carboplatin plus taxane plus pembrolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients with Newly Diagnosed Stage IV Squamous Cell Lung Cancers. Paik, PK., Kim, RK., Ahn, L., et al.[2022]

A phase I/II trial involving 46 patients with untreated advanced non-small cell lung cancer (NSCLC) demonstrated that the combination of carboplatin, nab-paclitaxel, and pembrolizumab is a safe and effective treatment, achieving a median overall survival of 15.4 months.

The study found a 35% overall response rate and a median progression-free survival of 5.6 months, indicating that this regimen can provide a durable benefit for patients, regardless of their PD-L1 status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non-Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175. Gentzler, RD., Mohindra, NA., Jalal, SI., et al.[2023]

A study analyzing 3,940 cases from the FDA Adverse Event Reporting System found that taxane-related neurotoxicity, particularly peripheral neuropathy, is common, especially among elderly patients and females.

The median time for neurological adverse effects to appear after taxane treatment was 27 days, with a significant portion of cases occurring within the first 30 days, and the study reported a fatality rate of 6.13% and hospitalization rate of 28.63% for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021. Zhang, J., Luo, L., Long, E., et al.[2023]

The combination of the oral taxane BMS-275183 and the monoclonal antibody cetuximab showed significant therapeutic synergy in preclinical models, achieving over 2.6 log cell kill in tumor-bearing mice, which is greater than the effects of either treatment alone.

This combination therapy was well-tolerated and resulted in tumor-free status in some mice, suggesting promising efficacy that warrants further clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic synergy of oral taxane BMS-275183 and cetuximab versus human tumor xenografts. Rose, WC., Wild, R.[2016]

Nab-paclitaxel was well tolerated in pediatric solid tumor models, with a maximum weight loss of about 10% that returned to baseline after treatment, indicating a favorable safety profile.

The treatment showed significant efficacy, improving event-free survival in 19 out of 20 solid tumor xenograft models, particularly demonstrating high activity against Ewing sarcoma and rhabdomyosarcoma, making it a promising candidate for further pediatric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). Houghton, PJ., Kurmasheva, RT., Kolb, EA., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Update on taxanes in the first-line treatment of advanced non-small-cell lung cancer. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of albumin-bound paclitaxel in treating recurrent advanced non-small-cell lung cancer. [2021]

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

Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial. [2021]

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

A Phase II Trial of Albumin-Bound Paclitaxel and Gemcitabine in Patients with Newly Diagnosed Stage IV Squamous Cell Lung Cancers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non-Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021. [2023]

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

Therapeutic synergy of oral taxane BMS-275183 and cetuximab versus human tumor xenografts. [2016]

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

Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP). [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nanoparticle albumin-bound paclitaxel in a patient with locally advanced breast cancer and taxane-induced skin toxicity: a case report. [2021]

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

Novel enhanced delivery taxanes: an update. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Bevacizumab in combination with taxanes for the first-line treatment of metastatic breast cancer. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Novel taxanes in development: Hopes or hypes? [2022]