Health TrialsbyHealthPanel

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

ConditionsHepatocellular CarcinomaPancreatic Ductal AdenocarcinomaBiliary Tract CancersEsophageal Squamous Cell CarcinomaTriple Negative Breast CancerHormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast CancerHead and Neck Squamous-Cell CarcinomaPlatinum Resistant High Grade Epithelial Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbVie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABBV-400

    Drug

    Intravenous (IV) Infusion

  • Itraconazole (ITZ)

    Drug

    Oral Solution

  • Bevacizumab

    Drug

    IV Infusion

Treatment groups

325 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Cohort 1: Hepatocellular Carcinoma (HCC)Experimental treatment 1 intervention
Group B: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)Experimental treatment 1 intervention
Group C: Cohort 3: Biliary Tract Cancers (BTC)Experimental treatment 1 intervention
Group D: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)Experimental treatment 1 intervention
Group E: Cohort 5: Triple Negative Breast Cancer (TNBC)Experimental treatment 1 intervention
Group F: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)Experimental treatment 1 intervention
Group G: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)Experimental treatment 1 intervention
Group H: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube CancerExperimental treatment 1 intervention
Group I: Cohort 9: Drug-Drug InteractionExperimental treatment 2 interventions
Group J: Cohort 10: PROC/Primary Peritoneal/Fallopian Tube CancerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 36 Months
2

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.

Time frame
Up to 36 Months
3

Maximum Observed Concentration (Cmax) of ABBV-400 Conjugate

Cmax of ABBV-400 conjugate.

Time frame
Up to 36 Months
4

AUC from Time 0 to the End of Dosing Interval (AUCtau) of ABBV-400 Conjugate

AUCtau of ABBV-400 conjugate.

Time frame
Up to 36 Months

Secondary outcomes

1

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.

Time frame
Up to 36 Months
2

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

Time frame
Up to 36 Months
3

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.

Time frame
Up to 36 Months
4

Overall Survival (OS)

OS is defined as time from first study treatment to death due to any cause.

Time frame
Up to 36 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov
Apply now