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Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
NCT04777994 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG ABBV-CLS-484
- DRUG Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)
- DRUG Programmed Cell Death-1 (PD-1) Inhibitor
Study Locations (20)
Texas
- University of Texas Southwestern Medical Center /ID# 251974 — Dallas
- University of Texas MD Anderson Cancer Center /ID# 252004 — Houston
- NEXT Oncology /ID# 225708 — San Antonio
Massachusetts
- Beth Israel Deaconess Medical Center /ID# 252009 — Boston
- Dana-Farber Cancer Institute /ID# 249642 — Boston
North Carolina
- Duke Cancer Center /ID# 251975 — Durham
- Carolina BioOncology Institute /ID# 225704 — Huntersville
Pennsylvania
- Perelman Center for Advanced Medicine /ID# 250188 — Philadelphia
- UPMC Hillman Cancer Ctr /ID# 225706 — Pittsburgh
Arizona
- University of Arizona Cancer Center - Tucson /ID# 262698 — Tucson
Connecticut
- Yale University School of Medicine /ID# 225707 — New Haven
Maryland
- Johns Hopkins Hospital /ID# 254056 — Baltimore
Michigan
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010 — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04777994
The ClinicalTrials.gov registry entry for NCT04777994 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calico Life Sciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumor Cancer appearing as the primary indexed condition, and to 3 interventions — of which ABBV-CLS-484 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04777994 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, Massachusetts, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04777994 about?
NCT04777994 is a clinical study titled "Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors". 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 effi...
What is the current status of trial NCT04777994?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 248 participants. The study started on 2021-03-09. Estimated completion is 2026-10.
What conditions does trial NCT04777994 study?
This clinical trial studies the following conditions: Advanced Solid Tumor Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04777994?
The interventions under investigation include: ABBV-CLS-484 (DRUG), Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) (DRUG), Programmed Cell Death-1 (PD-1) Inhibitor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04777994?
This trial is sponsored by Calico Life Sciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04777994 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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