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NCT05029882 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 520
- Enrollment target
- 20
- Study locations
NCT05029882: Active Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by AbbVie.
NCT05029882 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 520 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05029882, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 520 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 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 triflurid
Primary Outcome
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Trifluridine/Tipiracil
- DRUG ABBV-400
Study Locations (20)
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338 - Fort Wayne
- Indiana University Melvin and Bren Simon Cancer Center /ID# 245133 - Indianapolis
- Community Health Network, Inc. /ID# 245331 - Indianapolis
Texas
- MD Anderson Cancer Center at Texas Medical Center /ID# 248656 - Houston
- Oncology Consultants /ID# 267347 - Houston
- NEXT Oncology /ID# 231578 - San Antonio
North Carolina
- Duke Cancer Institute /ID# 247236 - Durham
- Carolina BioOncology Institute /ID# 231541 - Huntersville
California
- University of California, Los Angeles /ID# 243841 - Los Angeles
Colorado
- University Of Colorado Denver /ID# 231574 - Aurora
Connecticut
- Yale School of Medicine /ID# 248418 - New Haven
Illinois
- University of Illinois Hospital and Health Sciences System /ID# 251386 - Chicago
Louisiana
- Comprehensive Cancer Centers of Nevada /ID# 242930 - Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What the registry record for NCT05029882 still lists
NCT05029882 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (20% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT05029882 names 20 study sites across 15 states, led by Indiana, Texas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05029882 about?
NCT05029882 is a clinical study titled "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". 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...
What is the current status of trial NCT05029882?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 520 participants. The study started on 2021-10-13. Estimated completion is 2027-11.
What conditions does trial NCT05029882 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma.
What interventions are being tested in trial NCT05029882?
The interventions under investigation include: Bevacizumab (DRUG), Trifluridine/Tipiracil (DRUG), ABBV-400 (DRUG).
Who is sponsoring clinical trial NCT05029882?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05029882 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05029882's enrollment target sits among peer trials
520 72nd of 454 higher than 383 of 454 other Non-Small Cell Lung Cancer trials
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Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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