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
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-400: Intravenous (IV) Infusion
Trifluridine/Tipiracil: Oral Tablet
Bevacizumab: IV Infusion
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 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.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) — Up to 48 Months
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.
Trial sites (82)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Los Angeles /ID# 243841 | Los Angeles | California | |
| University Of Colorado Denver /ID# 231574 | Aurora | Colorado | |
| Yale School of Medicine /ID# 248418 | New Haven | Connecticut | |
| University of Illinois Hospital and Health Sciences System /ID# 251386 | Chicago | Illinois | |
| Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338 | Fort Wayne | Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 245133 | Indianapolis | Indiana | |
| Community Health Network, Inc. /ID# 245331 | Indianapolis | Indiana | |
| Comprehensive Cancer Centers of Nevada /ID# 242930 | Henderson | Louisiana | |
| START Midwest /ID# 231551 | Grand Rapids | Michigan | |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668 | New York | New York | |
| Duke Cancer Institute /ID# 247236 | Durham | North Carolina | |
| Carolina BioOncology Institute /ID# 231541 | Huntersville | North Carolina | |
| Duplicate_Gabrail Cancer Center Research /ID# 248419 | Canton | Ohio | |
| MD Anderson Cancer Center at Texas Medical Center /ID# 248656 | Houston | Texas | |
| Oncology Consultants /ID# 267347 | Houston | Texas | |
| NEXT Oncology /ID# 231578 | San Antonio | Texas | |
| Virginia Cancer Specialists - Fairfax /ID# 231575 | Fairfax | Virginia | |
| Northwest Medical Specialties Tacoma /ID# 267339 | Tacoma | Washington | |
| Mater Misericordiae Limited /ID# 249995 | South Brisbane | Queensland | |
| Austin Health /ID# 247667 | Heidelberg | Victoria | |
| Institut Bergonie /ID# 248028 | Bordeaux | Gironde | |
| CHU Nantes - Hopital Laennec /ID# 244723 | Saint-Herblain | Loire-Atlantique | |
| Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399 | Saint-Herblain | Loire-Atlantique | |
| Centre Antoine-Lacassagne /ID# 231730 | Nice | Provence-Alpes-Côte d'Azur Region | |
| Centre Leon Berard /ID# 250987 | Lyon | Rhone | |
| Institut Gustave Roussy /ID# 246824 | Villejuif | Val-de-Marne | |
| Centre Georges François Leclerc /ID# 244450 | Dijon | France | |
| AP-HP - Hopital Européen Georges Pompidou /ID# 250481 | Paris | France | |
| Meir Medical Center /ID# 244179 | Kfar Saba | Central District | |
| Hadassah Medical Center /ID# 243821 | Jerusalem | Jerusalem | |
| The Chaim Sheba Medical Center /ID# 231217 | Ramat Gan | Tel Aviv | |
| Tel Aviv Sourasky Medical Center /ID# 245271 | Tel Aviv | Tel Aviv | |
| Rambam Health Care Campus /ID# 231218 | Haifa | Israel | |
| Rabin Medical Center /ID# 243363 | Petah Tikva | Israel | |
| NHO Nagoya Medical Center /ID# 250286 | Nagoya | Aichi-ken | |
| Aichi Cancer Center Hospital /ID# 250284 | Nagoya | Aichi-ken | |
| National Cancer Center Hospital East /ID# 232008 | Kashiwa-shi | Chiba | |
| Yokohama Municipal Citizen's Hospital /ID# 248842 | Yokohama | Kanagawa | |
| Kyoto University Hospital /ID# 250291 | Kyoto | Kyoto | |
| Niigata University Medical & Dental Hospital /ID# 250952 | Niigata | Niigata |
+ 42 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05029882 on ClinicalTrials.gov ↗ ← All trials in Poland