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Clinical Trials List

Protocol NumberM21-404
NCT Number(ClinicalTrials.gov Identfier)NCT05029882
Active

2022-09-01 - 2025-12-31

Phase I

Not yet recruiting3

Recruiting8

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

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pai-Chien Chou Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Nan Yeh Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱倫瑋 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced Solid Tumors

Objectives

Main Purpose ‧ Evaluate the safety, tolerability and pharmacokinetics (PK) of ABBV-400 and determine Recommended Phase 2 Dose (RP2D) of ABBV-400 as Monotherapy ‧ To evaluate the efficacy of ABBV-400 in subjects with the following advanced solid tumors: Squamous NSCLC, squamous NSCLC, GEA, and CRC To evaluate ABBV-400 in subjects with advanced solid tumors with MET amplification Efficacy Secondary Purpose ‧ To evaluate the possible effect of ABBV-400 administration on QT wave prolongation

Test Drug

ABBV-400

Active Ingredient

ABBV-400

Dosage Form

Powder for Concentrate for Solution for Infusion

Dosage

100 mg

Endpoints

Main efficacy index
Patients with solid tumors were confirmed according to RECIST version 1.1.
Complete response (CR)/partial response (PR)

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    500 participants

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