What side effects are associated with this type of intervention?

Common treatments for cancer that modulate the immune response, such as PD-1 inhibitors, often cause side effects like fatigue, rash, diarrhea, and pneumonitis. Treatments targeting angiogenesis, such as VEGF TKIs, can lead to hypertension, proteinuria, and hand-foot syndrome. Both types of treatments can also cause more severe adverse events, including immune-related effects like colitis and hepatitis, as well as cardiovascular issues. Regular monitoring and supportive care are essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs that modulate the immune response or inhibit angiogenesis for cancer treatment. Pembrolizumab and nivolumab are immune checkpoint inhibitors targeting PD-1, approved for various cancers including melanoma and non-small cell lung cancer. Atezolizumab, another PD-1/PD-L1 inhibitor, is approved for similar indications. For angiogenesis inhibition, bevacizumab, a VEGF inhibitor, is approved for multiple cancers such as colorectal cancer and non-small cell lung cancer. These drugs share mechanisms of action with the investigational drug ABBV-CLS-579, which is being studied for its potential in modulating immune response and angiogenesis in tumor treatment.

What other types of research exist?

Promising alternatives to ABBV-CLS-579 for cancer treatment in 2024 include: 1) Anti-BCMA CAR T-Cell Therapy (e.g., bb2121) for multiple myeloma, which targets B-cell maturation antigen. 2) Teclistamab, a bispecific antibody targeting BCMA for multiple myeloma. 3) Combination therapies involving immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) with anti-VEGF agents (e.g., bevacizumab) for renal cell carcinoma. 4) Cabozantinib combined with atezolizumab for advanced renal cell carcinoma. These therapies are in advanced stages of clinical trials and show potential in modulating the immune response and inhibiting angiogenesis.

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ABBV-CLS-579 for Cancer

Phase 1

Recruiting

Research Sponsored by Calico Life Sciences LLC

Eligibility Criteria Checklist

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

Must have

For Combination Dose Expansion, subjects with specific tumor types must have received at least 1 prior line containing PD-1/PD-L1 target therapy as outlined for each tumor type

Histologically or cytologically proven metastatic or locally advanced tumors with measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered

Must not have

Known gastrointestinal disorders making absorption of oral medications problematic. Inability to swallow capsules

History of hemorrhage, including hemoptysis, hematemesis, or melena

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion (approximately 3 years)

Awards & highlights

Summary

This trial tests the safety and effectiveness of ABBV-CLS-579, a new drug for treating tumors. It includes patients with advanced cancers that haven't responded to other treatments. The drug is tested alone and with other cancer therapies to see if it can help the immune system fight cancer or cut off the tumor's blood supply.

Who is the study for?

Adults with certain advanced solid tumors, including specific types of lung cancer (NSCLC), head and neck cancer (HNSCC), and kidney cancer (ccRCC) that have not responded to standard treatments or for which no effective treatment exists. Participants must have tried a PD-1/PD-L1 therapy before, weigh at least 35 kg, have an ECOG performance status ≤2, life expectancy ≥12 weeks, meet laboratory value criteria, and be able to swallow capsules.

What is being tested?

The trial is testing ABBV-CLS-579 alone and in combination with a PD-1 inhibitor or VEGFR TKI on patients with advanced tumors. It's divided into three parts: dose escalation of ABBV-CLS-579 alone; dose escalation in combination with a PD-1 inhibitor; and expansion using the best dose found along with either a PD-1 inhibitor or VEGFR TKI for specific cancers.

What are the potential side effects?

Potential side effects include typical reactions associated with immunotherapy such as inflammation in various organs, infusion-related reactions like fever or chills during administration of the drug, fatigue from treatment burden, digestive issues due to medication intake method (swallowing pills), blood disorders from changes caused by the drugs' interaction within the body.

Eligibility Criteria

Inclusion Criteria

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

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I have had at least one treatment targeting PD-1/PD-L1 for my cancer type.

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My advanced cancer has no standard treatment left, but I've had at least one cancer treatment before.

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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 weigh at least 35 kilograms.

Exclusion Criteria

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

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I have a digestive issue that affects my ability to absorb pills or swallow capsules.

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I have had bleeding issues, like coughing up blood or bloody stools.

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I have a history of hepatitis B, C, or HIV.

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I have not had major surgery in the last 4 weeks.

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My liver disease was classified as moderate to severe in the last 6 months.

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I have a hormone disorder that is not well-controlled.

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I have not had heart failure, heart disease, or serious heart rhythm problems in the last 6 months.

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I have not been treated with drugs targeting PD-1/PD-L1 or other immune-boosting agents.

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My high blood pressure is not well-managed.

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I have had interstitial lung disease or pneumonitis.

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I currently have an active COVID-19 infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion (approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion (approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion (approximately 3 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

Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579

Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4

Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor

+21 more

Secondary study objectives

Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1

Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1

Change from Baseline QTc

+2 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Monotherapy Dose EscalationExperimental Treatment1 Intervention

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

Group II: Combination Expansion with VEGFR TKIExperimental Treatment2 Interventions

ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC.

Group III: Combination Expansion with PD-1Experimental Treatment2 Interventions

ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC)

Group IV: Combination Dose Escalation with PD-1Experimental Treatment2 Interventions

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

Group V: Backfill Cohorts with MonotherapyExperimental Treatment1 Intervention

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

Group VI: Backfill Cohorts in Combination with PD-1Experimental Treatment2 Interventions

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PD-1 inhibitor

2022

Completed Phase 2

~40

0 / 16Eligibility 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 cancer treatments include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects healthy cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors like PD-1/PD-L1 inhibitors, enhances the body's immune response against cancer cells. Treatments like ABBV-CLS-579, which potentially modulate the immune response or inhibit angiogenesis (the formation of new blood vessels that supply tumors), are crucial as they offer more precise and potentially less toxic options for patients. These mechanisms are significant because they aim to improve treatment efficacy while reducing side effects, ultimately enhancing the quality of life and survival rates for cancer patients.

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