What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as monoclonal antibodies and immune checkpoint inhibitors, often have side effects including infusion reactions, fatigue, and hematologic toxicities like neutropenia and anemia. Immune-related adverse events can also occur, such as pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapeutic agents like carboplatin and cisplatin may cause nausea, vomiting, nephrotoxicity, and neurotoxicity. These side effects vary in severity and frequency depending on the specific treatment regimen and patient factors.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors that target cancer cells or modulate the immune response. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and ipilimumab, which targets CTLA-4. These drugs have been approved for various cancers, including melanoma and non-small cell lung cancer. Additionally, targeted therapies like dabrafenib and trametinib, which inhibit BRAF and MEK pathways respectively, have been approved for BRAF-mutated melanoma. These treatments share similarities with ABBV-706 in their approach to targeting specific pathways or modulating the immune system to combat cancer.

What other types of research exist?

Promising novel alternatives to ABBV-706 for solid tumors include: 1) Pembrolizumab (Keytruda) combined with other agents like bevacizumab, showing efficacy in renal cell carcinoma. 2) Nivolumab (Opdivo) and ipilimumab (Yervoy) combination therapy, which has demonstrated improved treatment-free survival in metastatic melanoma. 3) Cabozantinib combined with atezolizumab, which has shown positive results in advanced renal cell carcinoma. 4) Regorafenib, a multitargeted kinase inhibitor, showing activity in advanced osteosarcoma. These alternatives are in various stages of clinical trials and have shown potential in targeting cancer cells and modulating the immune response.

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Monoclonal Antibodies

ABBV-706 + Chemotherapy for Advanced Solid Cancers

Phase 1

Recruiting

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ABBV-706, alone or with other drugs to treat aggressive cancers like small cell lung cancer and certain brain tumors. It aims to find the best dose and check its safety and effectiveness. The study involves periodic hospital visits and medical tests over several years.

Who is the study for?

Adults with advanced solid tumors, including specific types of lung cancer and high-grade brain or neuroendocrine cancers that have worsened despite standard treatments. Participants must be in good physical condition (ECOG 0-1), have acceptable heart function, and measurable disease. Those with certain lung conditions or previous treatment with similar drugs are excluded.

What is being tested?

The trial is testing ABBV-706 alone or combined with budigalimab, carboplatin, or cisplatin for treating various advanced cancers. It involves escalating doses to find the maximum tolerated dose and then further study at selected doses to assess safety and preliminary effectiveness.

What are the potential side effects?

Potential side effects include reactions related to infusion, organ inflammation like pneumonitis (lung issues), fatigue, blood abnormalities, digestive problems, increased risk of infections due to immune system effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Antidrug Antibodies (ADAs)

Plasma

Duration of response (DOR) for Participants with Confirmed CR/PR

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 4b: ABBV-706 Monotherapy Dose Expansion NECsExperimental Treatment1 Intervention

Participants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 1 year treatment period.

Group II: Part 4a: ABBV-706 Monotherapy Dose Expansion CNS TumorsExperimental Treatment1 Intervention

Participants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 1 year treatment period.

Group III: Part 3b: ABBV-706 + Platinum ChemotherapyExperimental Treatment3 Interventions

Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.

Group IV: Part 3a: ABBV-706 + BudigalimabExperimental Treatment2 Interventions

Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.

Group V: Part 2: ABBV-706 Monotherapy Dose Optimization and ExpansionExperimental Treatment1 Intervention

Participants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 1 year treatment period..

Group VI: Part 1: ABBV-706 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Budigalimab

2021

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 solid tumors often involve targeted therapies and immune checkpoint inhibitors. Targeted therapies, like ABBV-706, aim to directly attack cancer cells by interfering with specific molecules involved in tumor growth and progression. Immune checkpoint inhibitors, such as anti-PD-1 or anti-CTLA-4 antibodies, work by modulating the immune system to recognize and destroy cancer cells more effectively. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially less toxic treatment options compared to traditional chemotherapy, improving outcomes and quality of life.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Propelling Immunotherapy Combinations Into the Clinic.