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
Public ClinicalTrials.gov record NCT05599984. 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 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 319 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 4 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.
Study identification
- NCT ID
- NCT05599984
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 288 participants
Conditions and interventions
Conditions
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
- Dec 4, 2022
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
- Last update posted
- May 6, 2026
2022 – 2027
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Ctr /ID# 260129 | Gilbert | Arizona | 85234 | — |
| City Of Hope Comprehensive Cancer Center /ID# 271295 | Duarte | California | 91030 | — |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884 | Irvine | California | 92618 | — |
| Yale New Haven Hospital /ID# 246647 | New Haven | Connecticut | 06510 | — |
| Georgetown University Hospital /ID# 255352 | Washington D.C. | District of Columbia | 20007 | — |
| University of Chicago Medical Center /ID# 256334 | Chicago | Illinois | 60637 | — |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130 | Fort Wayne | Indiana | 46804 | — |
| University of Iowa Hospitals and Clinics /ID# 246638 | Iowa City | Iowa | 52242 | — |
| Barbara Ann Karmanos Cancer In /ID# 261799 | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital /ID# 246648 | Detroit | Michigan | 48202 | — |
| START Midwest /ID# 251257 | Grand Rapids | Michigan | 49546-7062 | — |
| St. Lukes Hosp. of Kansas City /ID# 259958 | Kansas City | Missouri | 64111 | — |
| Washington University-School of Medicine /ID# 246286 | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303 | New York | New York | 10065-6007 | — |
| Duke Cancer Center /ID# 246285 | Durham | North Carolina | 27710 | — |
| UH Cleveland Medical Center /ID# 246641 | Cleveland | Ohio | 44106 | — |
| Univ Oklahoma HSC /ID# 250884 | Oklahoma City | Oklahoma | 73117 | — |
| Tennessee Oncology, PLLC /ID# 246283 | Nashville | Tennessee | 37203 | — |
| University of Texas MD Anderson Cancer Center /ID# 246287 | Houston | Texas | 77030 | — |
| South Texas Accelerated Research Therapeutics /ID# 248946 | San Antonio | Texas | 78229 | — |
| University of Utah /ID# 246640 | Salt Lake City | Utah | 84112-5500 | — |
| Northwest Medical Specialties - Tacoma /ID# 262801 | Tacoma | Washington | 98405 | — |
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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05599984, 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 May 6, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05599984 live on ClinicalTrials.gov.