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

Phase 1

Recruiting

• Conditions: 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
• Interventions: Drug: ABBV-400

• Registration Number: NCT06084481
• Lead Sponsor: AbbVie

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. Each cohort receives ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 260 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 the each cohorts, 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 for up to 2 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-16
• Study Start: 2023-11-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Hepatocellular Carcinoma (HCC)	ABBV-400	Participants with HCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)	ABBV-400	Participants with PDAC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 3: Biliary Tract Cancers (BTC)	ABBV-400	Participants with BTC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)	ABBV-400	Participants with ESCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 5: Triple Negative Breast Cancer (TNBC)	ABBV-400	Participants with TNBC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)	ABBV-400	Participants with HR+/HER2-BC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)	ABBV-400	Participants with HNSCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer	ABBV-400	Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 24 Months	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR	Up to 24 Months	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.
Clinical Benefit Rate	Up to 24 Months	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
Progression-free Survival (PFS)	Up to 24 Months	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.
Overall Survival (OS)	Up to 24 Months	OS is defined as time from first study treatment to death due to any cause.
Maximum Observed Concentration (Cmax) of ABBV-400	Up to 24 Months	Cmax of ABBV-400.
Time to Cmax (Tmax) of ABBV-400	Up to 24 Months	Tmax of ABBV-400.
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration	Up to 24 Months	AUC for total antibody concentration.
Total Antibody Drug Conjugate (ADC) Concentration	Up to 24 Months	Total ADC concentration.
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload	Up to 24 Months	Plasma concentrations of unconjugated Top1 inhibitor payload.
Antidrug Antibody (ADA)	Up to 24 Months	Incidence and concentration of anti-drug antibodies.
Neutralizing Antidrug Antibody (nADA)	Up to 24 Months	Incidence and concentration of neutralizing anti-drug antibodies.

Trial Locations

Locations (53)

Chris O'Brien Lifehouse /ID# 262765; 🇦🇺 Camperdown, New South Wales, Australia

Rambam Health Care Campus /ID# 256649; 🇮🇱 Haifa, H_efa, Israel

Pan American Center for Oncology Trials /ID# 262903; 🇵🇷 Rio Piedras, Puerto Rico

Hospital Quirón Málaga /ID# 263994; 🇪🇸 Málaga, Malaga, Spain

Clinica Universidad de Navarra - Pamplona /ID# 256703; 🇪🇸 Pamplona, Navarra, Spain

Hospital HM Nou Delfos /ID# 263953; 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañón /ID# 262816; 🇪🇸 Madrid, Spain

Clinica Universidad de Navarra - Madrid /ID# 264042; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz /ID# 256702; 🇪🇸 Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 256701; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet /ID# 256704; 🇪🇸 Zaragoza, Spain

National Taiwan University Hospital /ID# 256713; 🇨🇳 Taipei City, Taipei, Taiwan

China Medical University Hospital /ID# 256712; 🇨🇳 Taichung, Taiwan

Linkou Chang Gung Memorial Hospital /ID# 259420; 🇨🇳 Taoyuan City, Taiwan

E-DA Cancer Hospital /ID# 258880; 🇨🇳 Kaohsiung City, Kaohsiung, Taiwan

Institut Català d'Oncologia (ICO) - Badalona /ID# 263954; 🇪🇸 Badalona, Barcelona, Spain

City of Hope National Medical Center /ID# 258645; 🇺🇸 Duarte, California, United States

Ucsf /Id# 257705; 🇺🇸 San Francisco, California, United States

University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128; 🇺🇸 Aurora, Colorado, United States

Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926; 🇺🇸 Denver, Colorado, United States

Florida Cancer Specialists /ID# 261569; 🇺🇸 Sarasota, Florida, United States

Northwestern University Feinberg School of Medicine /ID# 257378; 🇺🇸 Chicago, Illinois, United States

University of Chicago Medical Center /ID# 258197; 🇺🇸 Chicago, Illinois, United States

START Midwest /ID# 256581; 🇺🇸 Grand Rapids, Michigan, United States

Washington University-School of Medicine /ID# 257379; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132; 🇺🇸 New York, New York, United States

Duke Cancer Center /ID# 255129; 🇺🇸 Durham, North Carolina, United States

Univ Hosp Cleveland /ID# 257706; 🇺🇸 Cleveland, Ohio, United States

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771; 🇺🇸 Fairfax, Virginia, United States

Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693; 🇺🇸 Providence, Rhode Island, United States

MUSC Hollings Cancer Center /ID# 257935; 🇺🇸 Charleston, South Carolina, United States

Prisma Health /ID# 257697; 🇺🇸 Greenville, South Carolina, United States

Tennessee Oncology-Nashville Centennial /ID# 261568; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center /ID# 255131; 🇺🇸 Houston, Texas, United States

Univ Texas HSC San Antonio /ID# 257708; 🇺🇸 San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics /ID# 260404; 🇺🇸 San Antonio, Texas, United States

The Chaim Sheba Medical Center /ID# 255731; 🇮🇱 Ramat Gan, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 258931; 🇮🇱 Tel Aviv, Tel-Aviv, Israel

Rabin Medical Center /ID# 256650; 🇮🇱 Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 256655; 🇮🇱 Jerusalem, Israel

NHO Nagoya Medical Center /ID# 261001; 🇯🇵 Nagoya-shi, Aichi, Japan

Aichi Cancer Center Hospital /ID# 256679; 🇯🇵 Nagoya-shi, Aichi, Japan

National Cancer Center Hospital East /ID# 258934; 🇯🇵 Kashiwa-shi, Chiba, Japan

Kyoto University Hospital /ID# 256680; 🇯🇵 Kyoto-shi, Kyoto, Japan

Shizuoka Cancer Center /ID# 257789; 🇯🇵 Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 261136; 🇯🇵 Chuo-Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 257788; 🇯🇵 Koto-ku, Tokyo, Japan

Inje University Haeundae Paik Hospital /ID# 260118; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Chungbuk National University Hospital /ID# 256698; 🇰🇷 Cheongju, Chungcheongbugdo, Korea, Republic of

Gyeongsang National University Hospital /ID# 260408; 🇰🇷 Jinju, Gyeongsangnamdo, Korea, Republic of

Seoul National University Hospital /ID# 255730; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 258933; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Korea University Guro Hospital /ID# 256700; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of