ABBV-400
DrugIntravenous (IV) Infusion
NCT Number: NCT06084481
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 1
Chris O'Brien Lifehouse /ID# 262765, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV) Infusion
Oral Solution
Time frame: 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.
Time frame: 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.
Time frame: Up to 36 Months
Cmax of ABBV-400 conjugate.
Time frame: Up to 36 Months
AUCtau of ABBV-400 conjugate.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 36 Months
OS is defined as time from first study treatment to death due to any cause.
Time frame: Up to 36 Months
Cmax of ABBV-400.
Time frame: Up to 36 Months
Tmax of ABBV-400.
Time frame: Up to 36 Months
AUC for total antibody concentration.
Time frame: Up to 36 Months
Total ADC concentration.
Time frame: Up to 36 Months
Plasma concentrations of unconjugated Top1 inhibitor payload.
Time frame: Up to 36 Months
Incidence and concentration of anti-drug antibodies.
Time frame: Up to 36 Months
Incidence and concentration of neutralizing anti-drug antibodies.
Time frame: Up to 36 Months
Tmax of ABBV-400 conjugate.
Time frame: Up to 36 Months
Tmax of ABBV-400 unconjugated.
Time frame: Up to 36 Months
t1/2 of ABBV-400 conjugate.
Time frame: Up to 36 Months
t1/2 of ABBV-400 unconjugated.
Time frame: Up to 36 Months
Vss of ABBV-400 conjugate.
Time frame: Up to 36 Months
Vss of ABBV-400 unconjugated.
Time frame: Up to 36 Months
CLss of ABBV-400 conjugate.
Time frame: Up to 36 Months
CLss of ABBV-400 unconjugated.
AbbVie
Industry
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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