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Taking people in SpainPhase 1

Tests ABBV-400 alone or combined in adults with advanced solid tumors

Tests ABBV-400 in adults with advanced cancers of several organs.

Key facts

Who runs it
AbbVie
Where
Badalona, Barcelona, Madrid, Málaga, Pamplona, and Zaragoza, SpainSee the 9 sitesAlso in 7 other countries, 45 sites
Registry title
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Status
Recruiting
Phase
Phase 1
People taking part
325 people, planned
Started
9 Nov 2023
Expected to end
Sept 2027
Type of study
Interventional, 10 groups
Treatments tested
  • ABBV-400
  • Itraconazole (ITZ)
  • Bevacizumab
Record updated
14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain advanced solid tumors, such as liver, pancreatic, bile duct, esophageal, breast, head and neck, or ovarian cancer, who can receive ABBV-400.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic cancer of one of the listed types, with measurable disease (RECIST version 1.1) and disease activity as set out in the protocol.
Earlier treatment
Cannot have had anticancer treatment (chemotherapy, radiation, immunotherapy, biologic or investigational therapy) within 28 days or 5 half-lives of the drug, whichever is shorter, before the first dose. Palliative radiation for bone, skin or subcutaneous metastases with 10 fractions or less is allowed.
Biomarker or test result
Laboratory values must meet the criteria in the protocol.

Main reasons for not taking part

  • Unresolved side effects above Grade 1 from earlier cancer treatment
  • History of interstitial lung disease or pneumonitis treated with systemic steroids, or active lung disease of this kind
  • Untreated brain or meningeal metastases
  • Another active cancer, apart from those listed in the protocol
  • Autoimmune, connective tissue or inflammatory disorders with lung involvement, or a prior pneumonectomy

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Laboratory values meeting the criteria laid out in the protocol
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol

Who cannot take part

  • Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period
  • Unresolved clinically significant AEs > Grade 1 from prior anticancer therapy
  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol
  • Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy
  • History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol
  • Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required
  • History of other active malignancy, with the exception of those laid out in the protocol

Where in Spain

Also in 7 other countries, 45 sites

  • Institut Catala d Oncologia - ICO - Badalona /ID# 263954Badalona, SpainTaking people
  • Hospital HM Nou Delfos /ID# 263953Barcelona, SpainTaking people
  • Clinica Universidad de Navarra - Madrid /ID# 256703Madrid, SpainTaking people
  • Hospital General Universitario Gregorio Maranon /ID# 262816Madrid, SpainTaking people
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 256702Madrid, SpainTaking people
  • Hospital Universitario HM Sanchinarro /ID# 256701Madrid, SpainTaking people
  • Hospital Quiron Malaga /ID# 263994Málaga, SpainNo longer taking part
  • Clinica Universidad de Navarra - Pamplona /ID# 264042Pamplona, SpainTaking people
  • Hospital Universitario Miguel Servet /ID# 256704Zaragoza, SpainNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive [HR+]/HER2-breast cancer [BC]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide.

In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

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.

The 10 groups in the trial

  • Cohort 1: Hepatocellular Carcinoma (HCC)Treatment being tested

    Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)Treatment being tested

    Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 3: Biliary Tract Cancers (BTC)Treatment being tested

    Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)Treatment being tested

    Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 5: Triple Negative Breast Cancer (TNBC)Treatment being tested

    Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)Treatment being tested

    Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)Treatment being tested

    Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 8: PROC/Primary Peritoneal/Fallopian Tube CancerTreatment being tested

    Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400

  • Cohort 9: Drug-Drug InteractionTreatment being tested

    Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400 and Itraconazole (ITZ)

  • Cohort 10: PROC/Primary Peritoneal/Fallopian Tube CancerTreatment being tested

    Participants with PROC/primary peritoneal/fallopian tube cancer will receive ABBV-400 in combination with bevacizumab for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

    Treatment: ABBV-400 and Bevacizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Plain-language title
Tests ABBV-400 alone or combined in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 October 2026