Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab
Public ClinicalTrials.gov record NCT05029882. 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-400 as Monotherapy and in Combination With Bevacizumab 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 adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part 2iii\], GEA \[Part 3\] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion \[Part 4\], participants MET amplification will receive IV ABBV-400 monotherapy in expansion \[Part 5\], participants MET mutation will receive IV ABBV-400 monotherapy in expansion \[Part 6\], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab \[Part 7a\], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets \[Part 7b\]. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study identification
- NCT ID
- NCT05029882
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 520 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
- Oct 12, 2021
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Oct 28, 2025
2021 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Los Angeles /ID# 243841 | Los Angeles | California | 90095 | — |
| University Of Colorado Denver /ID# 231574 | Aurora | Colorado | 80045-2530 | — |
| Yale School of Medicine /ID# 248418 | New Haven | Connecticut | 06519 | — |
| University of Illinois Hospital and Health Sciences System /ID# 251386 | Chicago | Illinois | 60607 | — |
| Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338 | Fort Wayne | Indiana | 46825 | — |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 245133 | Indianapolis | Indiana | 46202-5112 | — |
| Community Health Network, Inc. /ID# 245331 | Indianapolis | Indiana | 46250-2042 | — |
| Comprehensive Cancer Centers of Nevada /ID# 242930 | Henderson | Louisiana | 89052 | — |
| START Midwest /ID# 231551 | Grand Rapids | Michigan | 49546-7062 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668 | New York | New York | 10065-6007 | — |
| Duke Cancer Institute /ID# 247236 | Durham | North Carolina | 27710 | — |
| Carolina BioOncology Institute /ID# 231541 | Huntersville | North Carolina | 28078 | — |
| Duplicate_Gabrail Cancer Center Research /ID# 248419 | Canton | Ohio | 44718 | — |
| MD Anderson Cancer Center at Texas Medical Center /ID# 248656 | Houston | Texas | 77030-4000 | — |
| Oncology Consultants /ID# 267347 | Houston | Texas | 77030 | — |
| NEXT Oncology /ID# 231578 | San Antonio | Texas | 78229 | — |
| Virginia Cancer Specialists - Fairfax /ID# 231575 | Fairfax | Virginia | 22031 | — |
| Northwest Medical Specialties Tacoma /ID# 267339 | 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 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05029882, 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 Oct 28, 2025 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05029882 live on ClinicalTrials.gov.