What side effects are associated with this type of intervention?

Common treatments for breast cancer include endocrine therapy, chemotherapy, and targeted therapies. Endocrine therapy, such as tamoxifen, can cause hot flashes, vaginal dryness, and an increased risk of blood clots. Aromatase inhibitors, like anastrozole, may lead to bone density loss, fractures, and cardiovascular risks. Chemotherapy often results in nausea, vomiting, hair loss, fatigue, and an increased risk of infections. Targeted therapies, such as trastuzumab, are generally well tolerated but can cause chills, fever, nausea, and, more seriously, cardiac dysfunction. These side effects should be discussed with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of breast cancer. Notable approvals include trastuzumab (Herceptin), a monoclonal antibody targeting HER2-positive breast cancer, and pertuzumab (Perjeta), which also targets HER2 and is used in combination with trastuzumab and chemotherapy. Additionally, palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) are CDK4/6 inhibitors approved for HR-positive, HER2-negative breast cancer. Immunotherapy options include pembrolizumab (Keytruda), an anti-PD-1 antibody, approved for triple-negative breast cancer. These treatments reflect a trend towards personalized medicine, targeting specific pathways involved in cancer growth and progression.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer. 2) Sacituzumab govitecan (Trodelvy), another antibody-drug conjugate for triple-negative breast cancer. 3) Pembrolizumab (Keytruda), an immune checkpoint inhibitor for PD-L1 positive breast cancer. 4) Alpelisib (Piqray), a PI3K inhibitor for HR-positive, HER2-negative breast cancer with PIK3CA mutations. 5) PARP inhibitors like olaparib (Lynparza) for BRCA-mutated breast cancer.

← Back to Search

Monoclonal Antibodies

ABBV-927 + ABBV-181 + Nab-paclitaxel + ABBV-368 + Carboplatin for Solid Tumors

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years since the first dose of study drug

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new drugs combined with chemotherapy to treat patients with certain types of solid tumors. It aims to understand how these treatments work together and their safety.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific types of breast and lung cancer. Participants must have adequate organ function and an ECOG performance status of 0 or 1. They should not have received certain prior treatments depending on their cancer type, and cannot join if they have uncontrolled brain metastases, recent major surgery, severe reactions to immune therapies, inflammatory bowel disease/pneumonitis, or other significant concurrent cancers.

What is being tested?

The study tests the safety and early effectiveness of ABBV-927 combined with ABBV-368, Budigalimab (ABBV-181), and/or chemotherapy in patients with selected solid tumors. It includes a dose-finding phase followed by a phase where more people receive the best dose found to be safe.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, hair loss; immunotherapy-related risks such as autoimmune reactions affecting various organs; infusion reactions; changes in blood counts leading to increased infection risk or bleeding tendencies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years since the first dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years since the first dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years since the first dose of study drug for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Expansion: Objective Response Rate (ORR)

Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368

Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181

Secondary study objectives

Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ)

Dose-Expansion Phase: Duration of Response (DOR)

Dose-Expansion Phase: Progression-free Survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Group I: Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimental Treatment3 Interventions

Participants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.

Group II: Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBCExperimental Treatment3 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.

Group III: Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBCExperimental Treatment2 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.

Group IV: Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBCExperimental Treatment3 Interventions

Participants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.

Group V: Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBCExperimental Treatment3 Interventions

Participants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.

Group VI: Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimental Treatment3 Interventions

Participants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.

Group VII: Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid TumorsExperimental Treatment2 Interventions

Participants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-181

2013

Completed Phase 1

~500

Nab-paclitaxel

2014

Completed Phase 3

~1950

ABBV-368

2017

Completed Phase 1

~170

Carboplatin

2014

Completed Phase 3

~6120

Do I qualify?Apply below to find out

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 breast cancer include CDK4/6 inhibitors, endocrine therapy, and immunotherapy. CDK4/6 inhibitors, such as palbociclib, work by blocking proteins that promote cell division, thereby slowing the growth of cancer cells. Endocrine therapies, like tamoxifen, target hormone receptors to reduce the growth signals in hormone receptor-positive breast cancer. Immunotherapy, including drugs like pembrolizumab, enhances the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment based on the cancer's specific characteristics, potentially improving outcomes and reducing resistance.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.CDK4/6 inhibitors in breast cancer - from in vitro models to clinical trials.Management of Brain and Leptomeningeal Metastases from Breast Cancer.