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NCT04777994 · ClinicalTrials.gov registry record · Phase 1
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
A Phase 1 study of Advanced Solid Tumor Cancer, sponsored by Calico Life Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT04777994: Recruiting Phase 1 study of Advanced Solid Tumor Cancer, sponsored by Calico Life Sciences.
NCT04777994 is a Phase 1 study of Advanced Solid Tumor Cancer that is actively recruiting participants, run by Calico Life Sciences. The registered enrollment target is 248 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04777994, a Phase 1 study of Advanced Solid Tumor Cancer, is actively recruiting participants, sponsored by Calico Life Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Maximum plasma/serum concentration of ABBV-CLS-484
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 |
What NCT04777994 shows while recruiting
NCT04777994 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher).
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.
NCT04777994 names 20 study sites across 15 states, led by Texas, Massachusetts, North Carolina.
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.
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).
Who is sponsoring clinical trial NCT04777994?
This trial is sponsored by Calico Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04777994's enrollment target sits among peer trials
248 186th of 2000 higher than 1,814 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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