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NCT05599984 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

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

Active
Registry status
Phase 1
Development phase
288
Enrollment target
20
Study locations

NCT05599984 is a Phase 1 study of Advanced Solid Tumors that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 288 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT05599984, a Phase 1 study of Advanced Solid Tumors, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
288 participants
Enrollment target
20
Study locations

Study Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Budigalimab
  • DRUG ABBV-706

Study Locations (20)

Michigan

  • Barbara Ann Karmanos Cancer In /ID# 261799 - Detroit
  • Henry Ford Hospital /ID# 246648 - Detroit
  • START Midwest /ID# 251257 - Grand Rapids

California

  • City Of Hope Comprehensive Cancer Center /ID# 271295 - Duarte
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884 - Irvine

Missouri

  • St. Lukes Hosp. of Kansas City /ID# 259958 - Kansas City
  • Washington University-School of Medicine /ID# 246286 - St Louis

Texas

  • University of Texas MD Anderson Cancer Center /ID# 246287 - Houston
  • South Texas Accelerated Research Therapeutics /ID# 248946 - San Antonio

Arizona

  • Banner MD Anderson Cancer Ctr /ID# 260129 - Gilbert

Connecticut

  • Yale New Haven Hospital /ID# 246647 - New Haven

District of Columbia

  • Georgetown University Hospital /ID# 255352 - Washington D.C.

Illinois

  • University of Chicago Medical Center /ID# 256334 - Chicago

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2022-12-05
Est. Completion 2026-06
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05599984

The ClinicalTrials.gov registry entry for NCT05599984 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (46% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.

NCT05599984 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Michigan, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT05599984 about?

NCT05599984 is a clinical study titled "Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors". Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-70...

What is the current status of trial NCT05599984?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 288 participants. The study started on 2022-12-05. Estimated completion is 2026-06.

What conditions does trial NCT05599984 study?

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

What interventions are being tested in trial NCT05599984?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Budigalimab (DRUG), ABBV-706 (DRUG).

Who is sponsoring clinical trial NCT05599984?

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

Where is trial NCT05599984 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.