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

NCT06084481 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: M24-4272023-506227-29-00
• Study Type: interventional
• Target: 302
• Locations: 8 countries
• Sites: 54

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) 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.

Conditions

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; Hepatocellular Carcinoma

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR

  Up to 36 Months

• Clinical Benefit Rate

  Up to 36 Months

• Progression-free Survival (PFS)

  Up to 36 Months

• Overall Survival (OS)

  Up to 36 Months

• Cmax of ABBV-400

  Up to 36 Months

Study Arms (9)

Cohort 1: Hepatocellular Carcinoma (HCC)

EXPERIMENTAL

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

Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)

EXPERIMENTAL

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

Cohort 3: Biliary Tract Cancers (BTC)

EXPERIMENTAL

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

Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)

EXPERIMENTAL

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

Cohort 5: Triple Negative Breast Cancer (TNBC)

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer

EXPERIMENTAL

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

Cohort 9: Drug-Drug Interaction

EXPERIMENTAL

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; Drug: Itraconazole (ITZ)

Interventions

ABBV-400 DRUG

Intravenous (IV) Infusion

Cohort 1: Hepatocellular Carcinoma (HCC); Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC); Cohort 3: Biliary Tract Cancers (BTC); Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC); Cohort 5: Triple Negative Breast Cancer (TNBC); Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC); Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC); Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer; Cohort 9: Drug-Drug Interaction

Itraconazole (ITZ) DRUG

Oral Solution

Cohort 9: Drug-Drug Interaction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

City of Hope National Medical Center /ID# 258645

Duarte, California, 91010, United States

Location

Ucsf /Id# 257705

San Francisco, California, 94143, United States

Location

University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128

Aurora, Colorado, 80045-7158, United States

Location

Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists /ID# 261569

Sarasota, Florida, 34232, United States

Location

Northwestern University Feinberg School of Medicine /ID# 257378

Chicago, Illinois, 60611-2927, United States

Location

University of Chicago Medical Center /ID# 258197

Chicago, Illinois, 60637, United States

Location

START Midwest /ID# 256581

Grand Rapids, Michigan, 49546-7062, United States

Location

Washington University-School of Medicine /ID# 257379

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132

New York, New York, 10065-6007, United States

Location

Duke Cancer Center /ID# 255129

Durham, North Carolina, 27710, United States

Location

Univ Hosp Cleveland /ID# 257706

Cleveland, Ohio, 44106, United States

Location

Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693

Providence, Rhode Island, 02903-4923, United States

Location

MUSC Hollings Cancer Center /ID# 257935

Charleston, South Carolina, 29425, United States

Location

Prisma Health /ID# 257697

Greenville, South Carolina, 29605, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 261568

Nashville, Tennessee, 37203-1632, United States

Location

MD Anderson Cancer Center /ID# 255131

Houston, Texas, 77030, United States

Location

Univ Texas HSC San Antonio /ID# 257708

San Antonio, Texas, 78229-3901, United States

Location

South Texas Accelerated Research Therapeutics /ID# 260404

San Antonio, Texas, 78229, United States

Location

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771

Fairfax, Virginia, 22031, United States

Location

Chris O'Brien Lifehouse /ID# 262765

Camperdown, New South Wales, 2050, Australia

Location

Austin Health /ID# 256635

Heidelberg, Victoria, 3084, Australia

Location

The Chaim Sheba Medical Center /ID# 255731

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 258931

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 256649

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 256655

Jerusalem, 91120, Israel

Location

Rabin Medical Center. /ID# 256650

Petah Tikva, 4941492, Israel

Location

NHO Nagoya Medical Center /ID# 261001

Nagoya, Aichi-ken, 460-0001, Japan

Location

Aichi Cancer Center Hospital /ID# 256679

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East /ID# 258934

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Kyoto University Hospital /ID# 256680

Kyoto, Kyoto, 606-8507, Japan

Location

Shizuoka Cancer Center /ID# 257789

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital /ID# 261136

Chuo-Ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital Of JFCR /ID# 257788

Koto-ku, Tokyo, 135-8550, Japan

Location

Pan American Center for Oncology Trials /ID# 262903

Rio Piedras, 00935, Puerto Rico

Location

Inje University Haeundae Paik Hospital /ID# 260118

Busan, Busan Gwang Yeogsi, 48108, South Korea

Location

Gyeongsang National University Hospital /ID# 260408

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Chungbuk National University Hospital /ID# 256698

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Seoul National University Hospital /ID# 255730

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 258933

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Korea University Guro Hospital /ID# 256700

Seoul, Seoul Teugbyeolsi, 08308, South Korea

Location

Institut Català d'Oncologia (ICO) - Badalona /ID# 263954

Badalona, Barcelona, 08916, Spain

Location

Hospital Quirón Málaga /ID# 263994

Málaga, Malaga, 29004, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 256703

Pamplona, Navarre, 31008, Spain

Location

Hospital HM Nou Delfos /ID# 263953

Barcelona, 08023, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 262816

Madrid, 28007, Spain

Location

Clinica Universidad de Navarra - Madrid /ID# 264042

Madrid, 28027, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 256702

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 256701

Madrid, 28050, Spain

Location

Hospital Universitario Miguel Servet /ID# 256704

Zaragoza, 50009, Spain

Location

E-DA Cancer Hospital /ID# 258880

Kaohsiung City, Kaohsiung, 82445, Taiwan

Location

National Taiwan University Hospital /ID# 256713

Taipei City, Taipei, 100, Taiwan

Location

China Medical University Hospital /ID# 256712

Taichung, 40447, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 259420

Taoyuan, 333, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Biliary Tract Neoplasms; Esophageal Squamous Cell Carcinoma; Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (20); KR (6); TW (4); AU (2); ES (9); JP (7); IL (5)