OncoMatch/Clinical Trials/NCT04777994
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Is NCT04777994 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ABBV-CLS-484 and Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) for advanced solid tumor cancer.
Treatment: ABBV-CLS-484 · Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) · Programmed Cell Death-1 (PD-1) Inhibitor — The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy 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). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anticancer therapy
must have received at least 1 prior systemic anticancer therapy for the indication being considered
Must have received: anti-PD-1 therapy — locally advanced or metastatic
must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable disease (for greater than 6 months)
Must have received: anti-PD-1 therapy — locally advanced or metastatic
must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6 months)
Must have received: anti-PD-1 therapy — locally advanced or metastatic
must have received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had disease progression with PD-1/PD-L1 targeted therapy
Must have received: VEGFR inhibitor — locally advanced or metastatic
Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
Cannot have received: anti-PD-1 therapy
Exception: if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation
If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past, excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation
Lab requirements
Blood counts
Laboratory values meeting protocol criteria
Kidney function
Laboratory values meeting protocol criteria
Liver function
Laboratory values meeting protocol criteria
Cardiac function
QT interval corrected for heart rate < 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings
Laboratory values meeting protocol criteria. QT interval corrected for heart rate < 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona Cancer Center - Tucson /ID# 262698 · Tucson, Arizona
- Yale University School of Medicine /ID# 225707 · New Haven, Connecticut
- Johns Hopkins Hospital /ID# 254056 · Baltimore, Maryland
- Beth Israel Deaconess Medical Center /ID# 252009 · Boston, Massachusetts
- Dana-Farber Cancer Institute /ID# 249642 · Boston, Massachusetts
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