Hepatocellular CarcinomaPhase 1NCT06084481
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 Phase 1 study testing ABBV-400, Itraconazole (ITZ) and Bevacizumab in people with Hepatocellular Carcinoma and Pancreatic Ductal Adenocarcinoma, run by AbbVie at 54 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers
- What is being tested?
- ABBV-400, Itraconazole (ITZ) and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 54 sitesin 8 countries
- Study dates
- 9 Nov 2023to Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
54 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 8 countries
United States20 sites, 19 recruiting
- Completed
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128
Aurora, Colorado, 80045-7158
- Recruiting
MUSC Hollings Cancer Center /ID# 257935
Charleston, South Carolina, 29425
- Recruiting
Northwestern Medicine - Northwestern Memorial Hospital /ID# 257378
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medical Center /ID# 258197
Chicago, Illinois, 60637
- Recruiting
Univ Hosp Cleveland /ID# 257706
Cleveland, Ohio, 44106
- Recruiting
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver, Colorado, 80218
- Recruiting
City of Hope National Medical Center /ID# 258645
Duarte, California, 91010
- Recruiting
Duke Cancer Center /ID# 255129
Durham, North Carolina, 27710
- Recruiting
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
Fairfax, Virginia, 22031
- Recruiting
START Midwest /ID# 256581
Grand Rapids, Michigan, 49546-7062
- Recruiting
Prisma Health /ID# 257697
Greenville, South Carolina, 29605
- Recruiting
MD Anderson Cancer Center /ID# 255131
Houston, Texas, 77030
- Recruiting
SCRI Oncology Partners /ID# 261568
Nashville, Tennessee, 37203
- Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132
New York, New York, 10065
- Recruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Providence, Rhode Island, 02903-4923
- Recruiting
Univ Texas HSC San Antonio /ID# 257708
San Antonio, Texas, 78229-3901
- Recruiting
South Texas Accelerated Research Therapeutics /ID# 260404
San Antonio, Texas, 78229
- Recruiting
UCSF Medical Center - Mount Zion /ID# 257705
San Francisco, California, 94115
- Recruiting
Florida Cancer Specialists- Sarasota Cattlemen /ID# 261569
Sarasota, Florida, 34232
- Recruiting
Washington University /ID# 257379
St Louis, Missouri, 63110
Spain9 sites, 7 recruiting
- Recruiting
Institut Catala d Oncologia - ICO - Badalona /ID# 263954
Badalona, Barcelona, 08916
- Recruiting
Hospital HM Nou Delfos /ID# 263953
Barcelona, 08023
- Recruiting
Hospital General Universitario Gregorio Maranon /ID# 262816
Madrid, 28007
- Recruiting
Clinica Universidad de Navarra - Madrid /ID# 256703
Madrid, 28027
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 256702
Madrid, 28040
- Recruiting
Hospital Universitario HM Sanchinarro /ID# 256701
Madrid, 28050
- Completed
Hospital Quiron Malaga /ID# 263994
Málaga, 29004
- Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 264042
Pamplona, Navarre, 31008
- Completed
Hospital Universitario Miguel Servet /ID# 256704
Zaragoza, 50009
Japan7 sites, 7 recruiting
- Recruiting
National Cancer Center Hospital /ID# 261136
Chuo-Ku, Tokyo, 104-0045
- Recruiting
National Cancer Center Hospital East /ID# 258934
Kashiwa-shi, Chiba, 277-8577
- Recruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 257788
Koto-ku, Tokyo, 135-8550
- Recruiting
Kyoto University Hospital /ID# 256680
Kyoto, Kyoto, 606-8507
- Recruiting
NHO Nagoya Medical Center /ID# 261001
Nagoya, Aichi-ken, 460-0001
- Recruiting
Aichi Cancer Center Hospital /ID# 256679
Nagoya, Aichi-ken, 464-8681
- Recruiting
Shizuoka Cancer Center /ID# 257789
Sunto-gun, Shizuoka, 411-8777
South Korea6 sites, 3 recruiting
- Recruiting
Inje University Haeundae Paik Hospital /ID# 260118
Busan, Busan Gwang Yeogsi, 48108
- Completed
Chungbuk National University Hospital /ID# 256698
Cheongju-si, North Chungcheong, 28644
- Completed
Gyeongsang National University Hospital /ID# 260408
Jinju, Gyeongsangnam-do, 52727
- Recruiting
Seoul National University Hospital /ID# 255730
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Samsung Medical Center /ID# 258933
Seoul, Seoul Teugbyeolsi, 06351
- Completed
Korea University Guro Hospital /ID# 256700
Seoul, Seoul Teugbyeolsi, 08308
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus /ID# 256649
Haifa, 3109601
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 256655
Jerusalem, 91120
- Recruiting
Rabin Medical Center. /ID# 256650
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 255731
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 258931
Tel Aviv, Tel Aviv, 6423906
Taiwan4 sites, 3 recruiting
- Recruiting
E-DA Cancer Hospital /ID# 258880
Kaohsiung City, Kaohsiung, 82445
- Recruiting
China Medical University Hospital /ID# 256712
Taichung, 40447
- Recruiting
National Taiwan University Hospital /ID# 256713
Taipei, 100
- Completed
Linkou Chang Gung Memorial Hospital /ID# 259420
Taoyuan City, 333
Australia2 sites, 2 recruiting
- Recruiting
Chris O'Brien Lifehouse /ID# 262765
Camperdown, New South Wales, 2050
- Recruiting
Austin Health /ID# 256635
Heidelberg, Victoria, 3084
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 262903
Rio Piedras, 00935
About this study
Official title: A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
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.
Read more
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.
- Conditions
- 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
- Being tested
- ABBV-400, Itraconazole (ITZ), Bevacizumab
- 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, bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-400Drug
Intravenous (IV) Infusion
Itraconazole (ITZ)Drug
Oral Solution
BevacizumabDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Hepatocellular Carcinoma (HCC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 3: Biliary Tract Cancers (BTC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 5: Triple Negative Breast Cancer (TNBC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) | Experimental | 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. Receives: Drug: ABBV-400 |
| Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer | Experimental | 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 years. Receives: Drug: ABBV-400 |
| Cohort 9: Drug-Drug Interaction | Experimental | 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. Receives: Drug: ABBV-400; Drug: Itraconazole (ITZ) |
| Cohort 10: PROC/Primary Peritoneal/Fallopian Tube Cancer | Experimental | Participants with PROC/primary peritoneal/fallopian tube cancer will receive ABBV-400 in combination with 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. Receives: Drug: ABBV-400; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 36 Months
Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate
Cmax of ABBV-400 conjugate.
Measured: Up to 36 Months
AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate
AUCtau of ABBV-400 conjugate.
Measured: Up to 36 Months
Secondary outcomes (19)
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.
Measured: 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
Measured: 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.
Measured: Up to 36 Months
Overall Survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Measured: Up to 36 Months
Cmax of ABBV-400
Cmax of ABBV-400.
Measured: Up to 36 Months
Time to Cmax (Tmax) of ABBV-400
Tmax of ABBV-400.
Measured: Up to 36 Months
Area Under the Plasma Concentration-time Curve (AUC) for Total Antibody Concentration
AUC for total antibody concentration.
Measured: Up to 36 Months
Total Antibody Drug Conjugate (ADC) Concentration
Total ADC concentration.
Measured: Up to 36 Months
Plasma Concentrations of Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload
Plasma concentrations of unconjugated Top1 inhibitor payload.
Measured: Up to 36 Months
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Measured: Up to 36 Months
Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of neutralizing anti-drug antibodies.
Measured: Up to 36 Months
Tmax of ABBV-400 Conjugate
Tmax of ABBV-400 conjugate.
Measured: Up to 36 Months
Tmax of ABBV-400 Unconjugated
Tmax of ABBV-400 unconjugated.
Measured: Up to 36 Months
Terminal Phase Elimination Half-Life (t1/2) of ABBV-400 Conjugate
t1/2 of ABBV-400 conjugate.
Measured: Up to 36 Months
t1/2 of ABBV-400 Unonjugated
t1/2 of ABBV-400 unconjugated.
Measured: Up to 36 Months
Volume of Distribution at Steady State (Vss) of ABBV-400 Conjugate
Vss of ABBV-400 conjugate.
Measured: Up to 36 Months
Vss of ABBV-400 Unconjugated
Vss of ABBV-400 unconjugated.
Measured: Up to 36 Months
Total Body Clearance at Steady State (CLss) of ABBV-400 Conjugate
CLss of ABBV-400 conjugate.
Measured: Up to 36 Months
CLss of ABBV-400 Unconjugated
CLss of ABBV-400 unconjugated.
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start9 Nov 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084481
- Sponsor's protocol ID
- M24-427
- Other IDs
- 2023-506227-29-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No