Esophageal Cancer Clinical Trial

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

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 220 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), or advanced solid tumors, will be enrolled in the study in approximately 60 sites worldwide.

In the each cohorts, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, and HNSCC 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.

View Eligibility Criteria

Eligibility Criteria

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), or head and neck squamous-cell-carcinoma (HNSCC) (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 AEs > Grade 1 from prior anticancer therapy except for alopecia.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor 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 is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT06084481

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 26 Locations for this study

See Locations Near You

City of Hope National Medical Center /ID# 258645
Duarte California, 91010, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver Colorado, 80218, United States
Florida Cancer Specialists /ID# 261569
Sarasota Florida, 34232, United States
Northwestern University Feinberg School of Medicine /ID# 257378
Chicago Illinois, 60611, United States
START Midwest /ID# 256581
Grand Rapids Michigan, 49546, United States
Washington University-School of Medicine /ID# 257379
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
New York New York, 10065, United States
Duke Cancer Center /ID# 255129
Durham North Carolina, 27710, United States
Univ Hosp Cleveland /ID# 257706
Cleveland Ohio, 44106, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Providence Rhode Island, 02903, United States
Prisma Health /ID# 257697
Greenville South Carolina, 29605, United States
Tennessee Oncology-Nashville Centennial /ID# 261568
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center /ID# 255131
Houston Texas, 77030, United States
Univ Texas HSC San Antonio /ID# 257708
San Antonio Texas, 78229, United States
South Texas Accelerated Research Therapeutics /ID# 260404
San Antonio Texas, 78229, United States
Rambam Health Care Campus /ID# 256649
Haifa H_efa, 31096, Israel
The Chaim Sheba Medical Center /ID# 255731
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 258931
Tel Aviv Tel-Aviv, 64239, Israel
Rabin Medical Center /ID# 256650
Haifa , 49414, Israel
Hadassah Medical Center-Hebrew University /ID# 256655
Jerusalem , 91120, Israel
NHO Nagoya Medical Center /ID# 261001
Nagoya-shi Aichi, 460-0, Japan
Aichi Cancer Center Hospital /ID# 256679
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East /ID# 258934
Kashiwa-shi Chiba, 277-8, Japan
Kyoto University Hospital /ID# 256680
Kyoto-shi Kyoto, 606-8, Japan
Shizuoka Cancer Center /ID# 257789
Sunto-gun Shizuoka, 411-8, Japan
The Cancer Institute Hospital Of JFCR /ID# 257788
Koto Tokyo, 135-8, Japan
Pan American Center for Oncology Trials /ID# 262903
Rio Piedras , 00935, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT06084481

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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