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NCT03000257 · ClinicalTrials.gov registry record · Phase 1

A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by AbbVie.

Completed
Registry status
Phase 1
Development phase
182
Enrollment target
20
Study locations

NCT03000257: Completed Phase 1 study of Advanced Solid Tumors, sponsored by AbbVie.

NCT03000257 is a Phase 1 study of Advanced Solid Tumors that has completed, run by AbbVie. The registered enrollment target is 182 participants, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target. The trial reports 20 study locations across 20 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03000257, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 1
Development phase
182 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

Primary Outcome

If a maximum tolerated dose (MTD) is reached, the RPTD of budigalimab will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and other available data.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG Venetoclax
  • DRUG ABBV-181
  • DRUG Rovalpituzumab Tesirine

Study Locations (20)

California

  • Moores Cancer Center at UC San Diego /ID# 157374 - La Jolla

Illinois

  • The University of Chicago Medical Center /ID# 157375 - Chicago

North Carolina

  • Carolina BioOncology Institute /ID# 157376 - Huntersville

Texas

  • South Texas Accelerated Research Therapeutics /ID# 157378 - San Antonio

Virginia

  • Virginia Cancer Specialists - Fairfax /ID# 157377 - Fairfax

New South Wales

  • Blacktown Hospital /ID# 167386 - Blacktown

Victoria

  • St Vincent's Hospital Melbourne /ID# 167552 - Fitzroy Melbourne

Western Australia

  • Linear Clinical Research /ID# 170797 - Nedlands

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2016-12-14
Est. Completion 2022-03-29
Phase Phase 1
AbbVie

526 total trials

What the finished NCT03000257 record still lists

NCT03000257 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT03000257 names 20 study sites across 20 states, led by California, Illinois, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03000257 about?

NCT03000257 is a clinical study titled "A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors". This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with ...

What is the current status of trial NCT03000257?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2016-12-14. Estimated completion is 2022-03-29.

What conditions does trial NCT03000257 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT03000257?

The interventions under investigation include: Venetoclax (DRUG), ABBV-181 (DRUG), Rovalpituzumab Tesirine (DRUG).

Who is sponsoring clinical trial NCT03000257?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03000257 being conducted?

This trial has 20 study locations across California, Illinois, North Carolina, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumors

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 NCT03000257's enrollment target sits among peer trials

182 47th of 144 higher than 98 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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Related registry views

Source: ClinicalTrials.gov NCT03000257, the US trial registry maintained by the National Library of Medicine. NCT03000257 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.