> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-assess-adverse-events-and-change-in-disease-49482a31-8ffa-48a6-8596-2179009f91f8 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Participants 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Start date 2023-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) Number of sites 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Short title** Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Official title** A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Dates **Completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **First posted** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Start date** 2023-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Size and sites **Participants** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Planned participants** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Number of sites** 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Identifiers **Registry ID** NCT06084481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **ClinicalTrials.gov ID** NCT06084481 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Outcomes ### Primary outcomes 1. Objective Response Rate (ORR) Timeframe: 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. 2. Number of Participants with Adverse Events (AEs) Timeframe: 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. 3. Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate Timeframe: Up to 36 Months Cmax of ABBV-400 conjugate. 4. AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate Timeframe: Up to 36 Months AUCtau of ABBV-400 conjugate. ### Secondary outcomes 1. Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR Timeframe: Up to 36 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. 2. Clinical Benefit Rate Timeframe: Up to 36 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 3. Progression-free Survival (PFS) Timeframe: Up to 36 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. 4. Overall Survival (OS) Timeframe: Up to 36 Months OS is defined as time from first study treatment to death due to any cause. 5. Cmax of ABBV-400 Timeframe: Up to 36 Months Cmax of ABBV-400. 6. Time to Cmax (Tmax) of ABBV-400 Timeframe: Up to 36 Months Tmax of ABBV-400. 7. Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration Timeframe: Up to 36 Months AUC for total antibody concentration. 8. Total Antibody Drug Conjugate (ADC) Concentration Timeframe: Up to 36 Months Total ADC concentration. 9. Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload Timeframe: Up to 36 Months Plasma concentrations of unconjugated Top1 inhibitor payload. 10. Antidrug Antibody (ADA) Timeframe: Up to 36 Months Incidence and concentration of anti-drug antibodies. 11. Neutralizing Antidrug Antibody (nADA) Timeframe: Up to 36 Months Incidence and concentration of neutralizing anti-drug antibodies. 12. Tmax of ABBV-400 Conjugate Timeframe: Up to 36 Months Tmax of ABBV-400 conjugate. 13. Tmax of ABBV-400 Unconjugated Timeframe: Up to 36 Months Tmax of ABBV-400 unconjugated. 14. Terminal Phase Elimination Half-Life (t1/2) of ABBV-400 Conjugate Timeframe: Up to 36 Months t1/2 of ABBV-400 conjugate. 15. t1/2 of ABBV-400 Unonjugated Timeframe: Up to 36 Months t1/2 of ABBV-400 unconjugated. 16. Volume of Distribution at Steady State (Vss) of ABBV-400 Conjugate Timeframe: Up to 36 Months Vss of ABBV-400 conjugate. 17. Vss of ABBV-400 Unconjugated Timeframe: Up to 36 Months Vss of ABBV-400 unconjugated. 18. Total Body Clearance at Steady State (CLss) of ABBV-400 Conjugate Timeframe: Up to 36 Months CLss of ABBV-400 conjugate. 19. CLss of ABBV-400 Unconjugated Timeframe: Up to 36 Months CLss of ABBV-400 unconjugated. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Sites - City of Hope National Medical Center /ID# 258645Duarte, United StatesActive, not recruiting - UCSF Medical Center - Mount Zion /ID# 257705San Francisco, United StatesCompleted - University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128Aurora, United StatesCompleted - Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926Denver, United StatesActive, not recruiting - Florida Cancer Specialists /ID# 261569Sarasota, United StatesActive, not recruiting - Northwestern University Feinberg School of Medicine /ID# 257378Chicago, United StatesActive, not recruiting - University of Chicago Medical Center /ID# 258197Chicago, United StatesActive, not recruiting - START Midwest /ID# 256581Grand Rapids, United StatesActive, not recruiting - Washington University-School of Medicine /ID# 257379St Louis, United StatesActive, not recruiting - Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132New York, United StatesActive, not recruiting - Duke Cancer Center /ID# 255129Durham, United StatesActive, not recruiting - Univ Hosp Cleveland /ID# 257706Cleveland, United StatesActive, not recruiting - Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693Providence, United StatesActive, not recruiting - MUSC Hollings Cancer Center /ID# 257935Charleston, United StatesCompleted - Prisma Health /ID# 257697Greenville, United StatesCompleted - Tennessee Oncology-Nashville Centennial /ID# 261568Nashville, United StatesActive, not recruiting - MD Anderson Cancer Center /ID# 255131Houston, United StatesCompleted - Univ Texas HSC San Antonio /ID# 257708San Antonio, United StatesActive, not recruiting - START-San AntonioSan Antonio, United StatesRecruiting - Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771Fairfax, United StatesCompleted - Chris O'Brien Lifehouse /ID# 262765Camperdown, AustraliaCompleted - Austin Health /ID# 256635Heidelberg, AustraliaCompleted - Rabin Medical Center. /ID# 256650Petah Tikva, IsraelCompleted - The Chaim Sheba Medical Center /ID# 255731Ramat Gan, IsraelCompleted - Tel Aviv Sourasky Medical Center /ID# 258931Tel Aviv, IsraelCompleted And 29 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## References ### Other registry identifiers (2) - 2023 - 2023-506227-29-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06084481) ## Related records ### Drugs (2) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (7) - [Biliary tract cancer](https://trialight.com/data/condition/biliary-tract-cancer-6b9535c9-ccaa-5b47-8c46-0d05d39d7c62.md) - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Primary condition - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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