- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2023-11-09
2026-07
2026-07
285
NCT06084481
AbbVie
AbbVie
INTERVENTIONAL
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
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) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 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 and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-10 | N/A | 2025-07-17 |
2023-10-10 | N/A | 2025-07-20 |
2023-10-16 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cohort 1: Hepatocellular Carcinoma (HCC) Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: ABBV-400
|
| EXPERIMENTAL: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: ABBV-400
|
| EXPERIMENTAL: Cohort 3: Biliary Tract Cancers (BTC) Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: ABBV-400
|
| EXPERIMENTAL: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: ABBV-400
|
| EXPERIMENTAL: Cohort 5: Triple Negative Breast Cancer (TNBC) Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: ABBV-400
|
| EXPERIMENTAL: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | |
| EXPERIMENTAL: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | |
| EXPERIMENTAL: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 y | |
| EXPERIMENTAL: Cohort 9: Drug-Drug Interaction Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. | DRUG: Itraconazole (ITZ)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | Up to 36 Months |
| Number of Participants with Adverse Events (AEs) | 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. | Up to 36 Months |
| Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate | Cmax of ABBV-400 conjugate. | Up to 36 Months |
| AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate | AUCtau of ABBV-400 conjugate. | Up to 36 Months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) for Participants with Confirmed Complete Response (CR)/PR | 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. | Up to 36 Months |
| Clinical Benefit Rate | 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 | Up to 36 Months |
| Progression-free Survival (PFS) | 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. | Up to 36 Months |
| Overall Survival (OS) | OS is defined as time from first study treatment to death due to any cause. | Up to 36 Months |
| Cmax of ABBV-400 | Cmax of ABBV-400. | Up to 36 Months |
| Time to Cmax (Tmax) of ABBV-400 | Tmax of ABBV-400. | Up to 36 Months |
| Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration | AUC for total antibody concentration. | Up to 36 Months |
| Total Antibody Drug Conjugate (ADC) Concentration | Total ADC concentration. | Up to 36 Months |
| Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload | Plasma concentrations of unconjugated Top1 inhibitor payload. | Up to 36 Months |
| Antidrug Antibody (ADA) | Incidence and concentration of anti-drug antibodies. | Up to 36 Months |
| Neutralizing Antidrug Antibody (nADA) | Incidence and concentration of neutralizing anti-drug antibodies. | Up to 36 Months |
| Tmax of ABBV-400 Conjugate | Tmax of ABBV-400 conjugate. | Up to 36 Months |
| Tmax of ABBV-400 Unconjugated | Tmax of ABBV-400 unconjugated. | Up to 36 Months |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-400 Conjugate | t1/2 of ABBV-400 conjugate. | Up to 36 Months |
| t1/2 of ABBV-400 Unonjugated | t1/2 of ABBV-400 unconjugated. | Up to 36 Months |
| Volume of Distribution at Steady State (Vss) of ABBV-400 Conjugate | Vss of ABBV-400 conjugate. | Up to 36 Months |
| Vss of ABBV-400 Unconjugated | Vss of ABBV-400 unconjugated. | Up to 36 Months |
| Total Body Clearance at Steady State (CLss) of ABBV-400 Conjugate | CLss of ABBV-400 conjugate. | Up to 36 Months |
| CLss of ABBV-400 Unconjugated | CLss of ABBV-400 unconjugated. | Up to 36 Months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: ABBVIE CALL CENTER Phone Number: 844-663-3742 Email: abbvieclinicaltrials@abbvie.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
