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Monoclonal Antibodies

ABBV-CLS-484 + PD-1/VEGFR Inhibitors for Cancer

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

An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Must weigh at least 35 kilograms (kg).

Must not have

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

Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion (approximately 3 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) in participants with advanced solid tumors.

Who is the study for?

This trial is for adults with advanced solid tumors who've tried at least one cancer therapy without success. They must be physically capable of daily activities, weigh over 35 kg, and have a life expectancy of at least 12 weeks. Certain conditions like uncontrolled high blood pressure or recent severe illnesses exclude participation.

What is being tested?

ABBV-CLS-484's safety and effectiveness are being tested alone or with other drugs targeting PD-1 or VEGFR in patients with specific cancers including head and neck squamous cell carcinoma, non-small cell lung cancer, and renal cell carcinoma. The study has three parts: dose escalation for monotherapy and combination therapy, followed by dose expansion.

What are the potential side effects?

Potential side effects may include issues related to the immune system attacking normal cells (autoimmune reactions), problems from drug infusion into the bloodstream (infusion reactions), fatigue, changes in blood pressure, bleeding risks, heart rhythm abnormalities (QT interval changes), as well as liver or kidney function alterations.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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I weigh at least 35 kg.

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My cancer is advanced, standard treatments failed, and I've had at least one cancer therapy.

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 currently have an active COVID-19 infection.

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I do not have ongoing severe numbness or pain in my hands or feet.

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I have had interstitial lung disease or pneumonitis.

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I can swallow capsules without issues.

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I have a history of serious hormone-related health issues that are not under control.

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

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I have had a solid organ or stem cell transplant.

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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.

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

Dose Escalation Time to Cmax (Tmax) of VEGFR TKI (Combination therapy)

Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-484 (Monotherapy)

Dose Escalation: Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor (Combination therapy)

+14 more

Secondary study objectives

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 And VEGFR TKI Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Combination therapy)

Dose Escalation: Objective Response Rate (ORR) Of ABBV-CLS-484 Based On (RECIST) v1.1 (Monotherapy)

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: Monotherapy ExpansionExperimental Treatment1 Intervention

ABBV-CLS-484 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), and advanced clear cell renal cell carcinoma (ccRCC)

Group II: Monotherapy Dose EscalationExperimental Treatment1 Intervention

ABBV-CLS-484 will be administered as a monotherapy in subjects with solid tumors

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

ABBV-CLS-484 will be administered at the determined recommended dose in combination with Programmed Cell Death-1 Inhibitor in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

Group IV: Combination ExpansionExperimental Treatment3 Interventions

ABBV-CLS-484 will be administered at the determined recommended dose in combination with VEGFR TKI in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

Group V: Combination Dose Escalation with VEGFR TKIExperimental Treatment2 Interventions

ABBV-CLS-484 will be administered in combination with a Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) in subjects with solid tumors

Group VI: Combination Dose Escalation with PD-1 InhibitorExperimental Treatment2 Interventions

ABBV-CLS-484 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

0 / 13Eligibility criteria met