ABBV-155 + Taxanes for Solid Cancers

Not currently recruiting at 53 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-155, both alone and with other drugs, to determine its safety and effectiveness for certain cancers. It targets individuals with small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or breast cancer that has recurred or not responded to previous treatments. Those with relapsed or hard-to-treat forms of these cancers after standard therapies might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABBV-155, whether used alone or with taxanes (a type of chemotherapy drug), is generally well-tolerated by patients. In earlier studies, patients taking ABBV-155 alone did not experience serious issues like low blood platelet or white blood cell counts, suggesting a manageable safety profile. When combined with paclitaxel, ABBV-155 also appeared safe, as no maximum tolerated dose (the highest dose without unacceptable side effects) was reached. This indicates the treatment might be safe for patients.

For ABBV-155 combined with docetaxel, previous studies indicate that docetaxel, when used with other treatments, has a safety record for patients with lung cancer. This provides some confidence that combining it with ABBV-155 could be safe, although more data is needed to confirm this.

Overall, these findings are promising, but it's important to remember that these are early studies focused on finding the best dose and ensuring the treatment is safe. Participants in clinical trials help researchers learn more about how these treatments work and their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-155 because it offers a new approach to treating solid tumors like breast cancer and lung cancer. Unlike traditional chemotherapy that kills both cancerous and healthy cells, ABBV-155 is designed to specifically target cancer cells, potentially reducing side effects. This treatment combines the power of a targeted therapy with taxanes like paclitaxel and docetaxel, which are already standard treatments, to enhance effectiveness. This innovative combination may provide a more potent attack on tumors while sparing healthy tissues, offering hope for improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for solid cancers?

Research has shown that ABBV-155, a targeted cancer treatment, holds promise against solid tumors, including small cell lung cancer (SCLC). In this trial, some participants will receive ABBV-155 alone, while others will receive it with taxanes. For breast cancer, one trial arm will test ABBV-155 combined with paclitaxel, potentially aiding patients unresponsive to other treatments. In non-small cell lung cancer (NSCLC), another arm will evaluate ABBV-155 with docetaxel, as docetaxel is already an established treatment for NSCLC. ABBV-155 aims to attack cancer cells while causing less harm to healthy cells, which could benefit the treatment of these challenging cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531008/

a meta-analysis of Phase III randomized controlled trials Docetaxel leads to a better result than vinca alkaloid in effectiveness and safety on patients with advanced non-small-cell lung cancer as first-line therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5312469/

Docetaxel in the treatment of non-small cell lung carcinoma Docetaxel, a semisynthetic taxane, was the first agent to show efficacy in the second-line treatment of non-small cell lung cancer (NSCLC), and has since become ...

3. sigma.larvol.com sigma.larvol.com/product.php?e1=769109&tab=newstrac

mirzotamab clezutoclax (ABBV-155) News ABBV-155, an antibody-drug conjugate targeting BCLX, where BCLX is being used as a payload to avoid “off-tumor” effects, demonstrated promise in solid tumor ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00675597

Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as ... The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side ...

5. oncoscience.us oncoscience.us/article/444/text/

Docetaxel increases the risk of severe infections in ... The purpose of this study was to determine whether docetaxel increases the risk of severe infections in patients with non-small cell lung cancer ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M16-573

A Study With ABBV-155 Alone and in Combination ... An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03595059

NCT03595059 | A Study With ABBV-155 Alone and in ... An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3027

Mirzotamab clezutoclax as monotherapy and in ... Mirzo-C demonstrated a tolerable safety profile as monotherapy and with taxanes. No thrombocytopenia or neutropenia was observed with monotherapy.

9. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)01086-4/fulltext

MO38-1 Phase 1 study of ABBV-155 ± paclitaxel in ... Primary outcomes were to determine maximum tolerated dose and recommended phase 2 dose; secondary outcomes included safety, PK, and response per RECIST v1.1.

10. medchemexpress.com medchemexpress.com/mirzotamab.html?srsltid=AfmBOorTxrJDjAlBqFMUwhT2ZtxGF-m8kK0aaFNskK2VoDHUOrdHFrcV

Mirzotamab | Anti-CD276/B7-H3 Antibody Mirzotamab clezutoclax (ABBV-155) is a targeted antibody drug conjugate (ADC). ... SAFETY DATA SHEET (SDS). English - EN (251 KB) Français - FR (251 KB) Deutsch ...