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Clinical Trials in Australia / NCT05029882
Active, not recruiting 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

NCT05029882 · tracked via the Priya Life Science Australia tracker
Sponsor
Phase
Phase 1
Started
2021-10-13
Last updated
2025-10-29

Condition(s) studied

Non-Small Cell Lung CancerAdvanced Solid TumorsGastroesophageal AdenocarcinomaColorectal Cancer

Investigational drug(s) / intervention(s)

ABBV-400 →Trifluridine/Tipiracil →Bevacizumab →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of malignant solid tumor (World Health Organization \[WHO\] criteria). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * For Part 2 only - advanced non-squamous squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least: * Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR NSCLC (Part 2i) and squamous NSCLC (Part 2iii). * Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI\[s\]) for non- squamous mutEGFR NSCLC (Part 2ii). * Must have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on * If applicable, an immune checkpoint inhibitor. * If applicable, appropriate available therapies, including HER2-directed therapies. Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. * For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on: * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine). * Oxaliplatin. * Irinotecan. * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab). * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept). * If applicable, targeted therapy * Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102) or Regorafenib treated participants are eligible. * For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible. For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. * Intolerant to the standard treatment are eligible * For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on: * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine) * Oxaliplatin * Irinotecan * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab) * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept) * If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Laboratory values meeting the criteria outlined in the protocol. Exclusion Criteria: * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan.. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol. * For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
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

📄 Avastin (bevacizumab) drug profile →

More AbbVie trials in Australia

Other trials for the same condition

Official registry record

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 Australia