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 study on Hepatocellular Cancer Liver Cancer Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer Squamous Cell Carcinoma Breast Cancer Triple-Negative Breast Cancer Head and Neck Squamous Cell Carcinoma Ovarian Cancer Solid Tumor Carcinoma Ovarian Epithelial Carcinoma Head and Neck Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
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, Carcinoma, Breast Neoplasms, Squamous Cell Carcinoma, Adenocarcinoma, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Biliary Tract Neoplasms, Hepatocellular Carcinoma (HCC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancers (BTC), Esophageal Squamous Cell Carcinoma, (ESCC), Triple Negative Breast Cancer (TNBC), Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC), Head and Neck Squamous-cell-carcinoma (HNSCC)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 CAN'T join 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.
Locations
- UCSF /Id# 257705
accepting new patients
San Francisco California 94143 United States - City of Hope National Medical Center /ID# 258645
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AbbVie
- Links
- Related Info
- ID
- NCT06084481
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 260 study participants
- Last Updated
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT06084481.