What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as monoclonal antibodies and chemotherapeutic agents like paclitaxel and docetaxel, often result in a range of side effects. These can include hematologic toxicities like neutropenia, anemia, and thrombocytopenia, as well as non-hematologic toxicities such as fatigue, neuropathy, diarrhea, and rash. Specific agents may also cause unique side effects; for example, paclitaxel and docetaxel are known for causing peripheral neuropathy and hypersensitivity reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), which are checkpoint inhibitors targeting the PD-1 pathway, used in various cancers such as melanoma, non-small cell lung cancer (NSCLC), and head and neck cancers. Another example is bevacizumab (Avastin), an anti-VEGF monoclonal antibody used in colorectal cancer, NSCLC, and glioblastoma. These therapies, like ABBV-155, aim to interfere with specific pathways or cells involved in cancer progression, offering more precise treatment options.

What other types of research exist?

Promising novel alternatives to ABBV-155 for solid tumor patients include multitargeted kinase inhibitors like regorafenib, cabozantinib, sorafenib, and lenvatinib, which target VEGFR and other kinases. Additionally, immune checkpoint inhibitors such as pembrolizumab, nivolumab, and combination therapies like nivolumab with ipilimumab or atezolizumab with bevacizumab are also emerging as effective treatments for various solid tumors.

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Monoclonal Antibodies

ABBV-155 + Taxanes for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a histologic or cytologic diagnosis of a malignant solid tumor.

Locally advanced or metastatic HR-positive/HER2-negative breast cancer after failing cyclin-dependent kinase (CDK)4/6 inhibitor-based therapy.

Must not have

Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.

Any history of hypersensitivity to any ingredients of ABBV-155 will be excluded. For combination therapy only (Parts 1b and 2b), no history of serious allergic reaction to any taxane or any ingredients used in taxane formulation (e.g., cremaphor).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 to 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to the immune system due to ABBV-155, issues from taxane therapy like nerve damage (neuropathy), as well as common chemotherapy-related effects such as fatigue, digestive problems, blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a solid tumor cancer.

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My breast cancer is advanced, HR-positive/HER2-negative and didn't respond to CDK4/6 inhibitor therapy.

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My cancer is HR-positive and HER2-negative according to specific medical standards.

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I can take care of myself and am up and about more than half of my waking hours.

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I have had taxane-based therapy for my breast or lung cancer.

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I have tried at least one chemotherapy treatment without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not allergic to ABBV-155 or any taxane ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD and/or RPTD of ABBV-155

Overall Response Rate (ORR)

Secondary study objectives

AUCinf of ABBV-155

AUCt of ABBV-155

Cmax of ABBV-155

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Expansion 2b: ABBV-155 + paclitaxel in Breast CancerExperimental Treatment2 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 NSCLCExperimental Treatment2 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 SCLCExperimental Treatment1 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 docetaxelExperimental Treatment3 Interventions

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

Group V: Escalation 1a: ABBV-155Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Paclitaxel

2011

Completed Phase 4

~5370

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often involve targeted therapies and chemotherapies. Targeted therapies, like ABBV-155, are designed to interfere with specific molecules involved in tumor growth and progression, such as proteins or genes that control cell division and survival. For example, ABBV-155 targets specific pathways or cells that are crucial for cancer cell survival. Taxane-based chemotherapies, such as paclitaxel and docetaxel, work by stabilizing microtubules and preventing cell division, leading to cancer cell death. These treatments are significant for solid tumor patients as they offer a more precise approach to attacking cancer cells while potentially reducing damage to normal cells, thereby improving treatment efficacy and reducing side effects.