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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
NCT05599984 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
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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. 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 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 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 Tumors appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin 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: NCT05599984 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Michigan, California, Missouri. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05599984?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Budigalimab (DRUG), ABBV-706 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05599984?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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