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) — Australia Trial Details

Condition(s) studied

Hepatocellular CarcinomaPancreatic Ductal AdenocarcinomaBiliary Tract CancersEsophageal Squamous Cell CarcinomaTriple Negative Breast CancerHormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast CancerHead and Neck Squamous-Cell CarcinomaPlatinum Resistant High Grade Epithelial Ovarian Cancer

Investigational drug(s) / intervention(s)

ABBV-400 →Itraconazole (ITZ) →Bevacizumab →

ABBV-400: Intravenous (IV) Infusion

Itraconazole (ITZ): Oral Solution

Bevacizumab: IV Infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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.

Primary outcome measure(s)

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

Trial sites (54)

Facility	City	Region	Status
City of Hope National Medical Center /ID# 258645	Duarte	California	Active Not Recruiting
UCSF Medical Center - Mount Zion /ID# 257705	San Francisco	California	Completed
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128	Aurora	Colorado	Completed
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926	Denver	Colorado	Active Not Recruiting
Florida Cancer Specialists /ID# 261569	Sarasota	Florida	Active Not Recruiting
Northwestern University Feinberg School of Medicine /ID# 257378	Chicago	Illinois	Active Not Recruiting
University of Chicago Medical Center /ID# 258197	Chicago	Illinois	Active Not Recruiting
START Midwest /ID# 256581	Grand Rapids	Michigan	Active Not Recruiting
Washington University-School of Medicine /ID# 257379	St Louis	Missouri	Active Not Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132	New York	New York	Active Not Recruiting
Duke Cancer Center /ID# 255129	Durham	North Carolina	Active Not Recruiting
Univ Hosp Cleveland /ID# 257706	Cleveland	Ohio	Active Not Recruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693	Providence	Rhode Island	Active Not Recruiting
MUSC Hollings Cancer Center /ID# 257935	Charleston	South Carolina	Completed
Prisma Health /ID# 257697	Greenville	South Carolina	Completed
Tennessee Oncology-Nashville Centennial /ID# 261568	Nashville	Tennessee	Active Not Recruiting
MD Anderson Cancer Center /ID# 255131	Houston	Texas	Completed
Univ Texas HSC San Antonio /ID# 257708	San Antonio	Texas	Active Not Recruiting
START-San Antonio	San Antonio	Texas	Recruiting
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771	Fairfax	Virginia	Completed
Chris O'Brien Lifehouse /ID# 262765	Camperdown	New South Wales	Completed
Austin Health /ID# 256635	Heidelberg	Victoria	Completed
Rabin Medical Center. /ID# 256650	Petah Tikva	Central District	Completed
The Chaim Sheba Medical Center /ID# 255731	Ramat Gan	Tel Aviv	Completed
Tel Aviv Sourasky Medical Center /ID# 258931	Tel Aviv	Tel Aviv	Completed
Rambam Health Care Campus /ID# 256649	Haifa	Israel	Active Not Recruiting
Hadassah Medical Center-Hebrew University /ID# 256655	Jerusalem	Israel	Active Not Recruiting
NHO Nagoya Medical Center /ID# 261001	Nagoya	Aichi-ken	Completed
Aichi Cancer Center Hospital /ID# 256679	Nagoya	Aichi-ken	Completed
National Cancer Center Hospital East /ID# 258934	Kashiwa-shi	Chiba	Active Not Recruiting
Kyoto University Hospital /ID# 256680	Kyoto	Kyoto	Active Not Recruiting
Shizuoka Cancer Center /ID# 257789	Sunto-gun	Shizuoka	Active Not Recruiting
National Cancer Center Hospital /ID# 261136	Chuo-Ku	Tokyo	Active Not Recruiting
The Cancer Institute Hospital Of JFCR /ID# 257788	Koto-ku	Tokyo	Active Not Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 262903	Rio Piedras	Puerto Rico	Completed
Inje University Haeundae Paik Hospital /ID# 260118	Busan	Busan Gwang Yeogsi	Completed
Gyeongsang National University Hospital /ID# 260408	Jinju	Gyeongsangnam-do	Completed
Chungbuk National University Hospital /ID# 256698	Cheongju-si	North Chungcheong	Completed
Seoul National University Hospital /ID# 255730	Seoul	Seoul Teugbyeolsi	Completed
Samsung Medical Center /ID# 258933	Seoul	Seoul Teugbyeolsi	Completed

+ 14 more sites — see the full list on the official registry below.

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