Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

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) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 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 and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of 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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatocellular Carcinoma; Triple Negative Breast Cancer; Pancreatic Ductal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Biliary Tract Cancers; Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer; Head and Neck Squamous-Cell Carcinoma; Platinum Resistant High Grade Epithelial Ovarian Cancer
• Intervention / Treatment: Drug: ABBV-400; Drug: Itraconazole (ITZ)

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse /ID# 262765
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health /ID# 256635
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 256649
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center-Hebrew University /ID# 256655
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center. /ID# 256650
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 255731
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 258931
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • NHO Nagoya Medical Center /ID# 261001
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 256679
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 258934
  • Kyoto
    • Kyoto, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 256680
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 257789
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 261136
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 257788
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials /ID# 262903
• South Korea
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 48108
      • Inje University Haeundae Paik Hospital /ID# 260118
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Gyeongsang National University Hospital /ID# 260408
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital /ID# 256698
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 255730
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 258933
    • Seoul, Seoul Teugbyeolsi, South Korea, 08308
      • Korea University Guro Hospital /ID# 256700
• Spain
  • Barcelona, Spain, 08023
    • Hospital HM Nou Delfos /ID# 263953
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 262816
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra - Madrid /ID# 264042
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 256702
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 256701
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet /ID# 256704
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Català d'Oncologia (ICO) - Badalona /ID# 263954
  • Malaga
    • Málaga, Malaga, Spain, 29004
      • Hospital Quirón Málaga /ID# 263994
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 256703
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 256712
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 259420
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 82445
      • E-DA Cancer Hospital /ID# 258880
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 256713
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center /ID# 258645
    • San Francisco, California, United States, 94143
      • Ucsf /Id# 257705
  • Colorado
    • Aurora, Colorado, United States, 80045-7158
      • University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists /ID# 261569
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 257378
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center /ID# 258197
  • Michigan
    • Grand Rapids, Michigan, United States, 49546-7062
      • START Midwest /ID# 256581
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 257379
  • New York
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center /ID# 255129
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 257706
  • Rhode Island
    • Providence, Rhode Island, United States, 02903-4923
      • Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Hollings Cancer Center /ID# 257935
    • Greenville, South Carolina, United States, 29605
      • Prisma Health /ID# 257697
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 261568
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /ID# 255131
    • San Antonio, Texas, United States, 78229-3901
      • Univ Texas HSC San Antonio /ID# 257708
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics /ID# 260404
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion
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.	Drug: ABBV-400; Intravenous (IV) Infusion; Drug: Itraconazole (ITZ); Oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR defined as percentage of participants with confirmed best overall response of confirmed partial response (PR) or better per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to 36 Months
Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to 36 Months
Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate	Cmax of ABBV-400 conjugate.	Up to 36 Months
AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate	AUCtau of ABBV-400 conjugate.	Up to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR	DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.	Up to 36 Months
Clinical Benefit Rate	CBR is defined as the proportion of participants with a best overall response of stable disease at least 5 weeks post first dose, confirmed CR or PR per investigator review according to RECIST, version 1.1	Up to 36 Months
Progression-free Survival (PFS)	PFS is defined as time from first study treatment to a documented disease progression according to RECIST, version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.	Up to 36 Months
Overall Survival (OS)	OS is defined as time from first study treatment to death due to any cause.	Up to 36 Months
Cmax of ABBV-400	Cmax of ABBV-400.	Up to 36 Months
Time to Cmax (Tmax) of ABBV-400	Tmax of ABBV-400.	Up to 36 Months
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration	AUC for total antibody concentration.	Up to 36 Months
Total Antibody Drug Conjugate (ADC) Concentration	Total ADC concentration.	Up to 36 Months
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload	Plasma concentrations of unconjugated Top1 inhibitor payload.	Up to 36 Months
Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 36 Months
Neutralizing Antidrug Antibody (nADA)	Incidence and concentration of neutralizing anti-drug antibodies.	Up to 36 Months
Tmax of ABBV-400 Conjugate	Tmax of ABBV-400 conjugate.	Up to 36 Months
Tmax of ABBV-400 Unconjugated	Tmax of ABBV-400 unconjugated.	Up to 36 Months
Terminal Phase Elimination Half-Life (t1/2) of ABBV-400 Conjugate	t1/2 of ABBV-400 conjugate.	Up to 36 Months
t1/2 of ABBV-400 Unonjugated	t1/2 of ABBV-400 unconjugated.	Up to 36 Months
Volume of Distribution at Steady State (Vss) of ABBV-400 Conjugate	Vss of ABBV-400 conjugate.	Up to 36 Months
Vss of ABBV-400 Unconjugated	Vss of ABBV-400 unconjugated.	Up to 36 Months
Total Body Clearance at Steady State (CLss) of ABBV-400 Conjugate	CLss of ABBV-400 conjugate.	Up to 36 Months
CLss of ABBV-400 Unconjugated	CLss of ABBV-400 unconjugated.	Up to 36 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Pancreatic Ductal Adenocarcinoma; Advanced Solid Tumors; Triple Negative Breast Cancer; Solid Tumors; Esophageal Squamous Cell Carcinoma; ABBV-400; Head and Neck Squamous-Cell Carcinoma; Biliary Tract Cancers; Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer; Platinum Resistant High Grade Epithelial Ovarian Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Biliary Tract Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Esophageal Diseases; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Breast Neoplasms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Biliary Tract Neoplasms; Carcinoma, Hepatocellular; Triple Negative Breast Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Piperazines; Itraconazole
• Other Study ID Numbers: M24-427; 2023-506227-29-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No