Recruiting
Phase 1

ABBV-400

Sponsor:

AbbVie

Code:

NCT06084481

Conditions

Hepatocellular Carcinoma

Pancreatic Ductal Adenocarcinoma

Biliary Tract Cancers

Esophageal Squamous Cell Carcinoma

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-400

Itraconazole (ITZ)

Bevacizumab

Study Details

Brief 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 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.

Conditions

Hepatocellular Carcinoma

Pancreatic Ductal Adenocarcinoma

Biliary Tract Cancers

Esophageal Squamous Cell Carcinoma

Triple Negative Breast Cancer

Study ID

NCT06084481

Start date

Nov 9, 2023

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • 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.

Study Design

Enrollment

325 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Hepatocellular Carcinoma (HCC)

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.

experimental: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)

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.

experimental: Cohort 3: Biliary Tract Cancers (BTC)

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.

experimental: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)

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.

experimental: Cohort 5: Triple Negative Breast Cancer (TNBC)

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.

experimental: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)

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.

experimental: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)

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.

experimental: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer

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.

experimental: Cohort 9: Drug-Drug Interaction

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.

experimental: Cohort 10: PROC/Primary Peritoneal/Fallopian Tube Cancer

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.

Interventions

ABBV-400

Intravenous (IV) Infusion

Itraconazole (ITZ)

Oral Solution

Bevacizumab

IV Infusion

Primary outcome measure

  • Objective Response Rate (ORR) [ Time Frame: Up to 36 Months ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 36 Months ]
  • Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate [ Time Frame: Up to 36 Months ]
  • AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate [ Time Frame: Up to 36 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

START-San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

HOPE Team

210-593-5250hopeteam@startresearch.com

Principal Investigator:

Dr. Papadopoulos

More Information

Sponsor

AbbVie

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Hepatocellular Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancers
  • Esophageal Squamous Cell Carcinoma
  • Triple Negative Breast Cancer
  • Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
  • Head and Neck Squamous-Cell Carcinoma
  • Platinum Resistant High Grade Epithelial Ovarian Cancer
  • Solid Tumors
  • Advanced Solid Tumors
  • ABBV-400
  • bevacizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-24.