Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
Public ClinicalTrials.gov record NCT04777994. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-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 ABBV-CLS-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.
Study identification
- NCT ID
- NCT04777994
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Interventions
- ABBV-CLS-484 Drug
- Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI) Drug
- Programmed Cell Death-1 (PD-1) Inhibitor Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2021
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
- Last update posted
- Jun 3, 2026
2021 – 2026
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center - Tucson /ID# 262698 | Tucson | Arizona | 85724 | Recruiting |
| Yale University School of Medicine /ID# 225707 | New Haven | Connecticut | 06510 | Recruiting |
| Johns Hopkins Hospital /ID# 254056 | Baltimore | Maryland | 21287 | Recruiting |
| Beth Israel Deaconess Medical Center /ID# 252009 | Boston | Massachusetts | 02215-5400 | Recruiting |
| Dana-Farber Cancer Institute /ID# 249642 | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 252010 | Ann Arbor | Michigan | 48109 | Recruiting |
| NYU Laura and Isaac Perlmutter Cancer Center - 34th Street /ID# 257869 | New York | New York | 10016 | Recruiting |
| Duke Cancer Center /ID# 251975 | Durham | North Carolina | 27710 | Recruiting |
| Carolina BioOncology Institute /ID# 225704 | Huntersville | North Carolina | 28078 | Completed |
| Perelman Center for Advanced Medicine /ID# 250188 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| UPMC Hillman Cancer Ctr /ID# 225706 | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 225705 | Providence | Rhode Island | 02903-4923 | Recruiting |
| University of Texas Southwestern Medical Center /ID# 251974 | Dallas | Texas | 75390-7208 | Recruiting |
| University of Texas MD Anderson Cancer Center /ID# 252004 | Houston | Texas | 77030 | Recruiting |
| NEXT Oncology /ID# 225708 | San Antonio | Texas | 78229 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04777994, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04777994 live on ClinicalTrials.gov.