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
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
325
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Lead sponsor
AbbVie
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Start date
2023-11-09
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Number of sites
54
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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.
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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
clinicaltrials.gov
Official title
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-09-01
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First posted
2023-10-16
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Registry last updated
2026-08-24
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Primary completion date
2027-09-01
clinicaltrials.gov
Start date
2023-11-09
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Participants
325
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Participant count basis
Estimated
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Planned participants
325
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Protocol amendments
6
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Number of sites
54
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06084481
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ClinicalTrials.gov ID
NCT06084481
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2023
  • 2023-506227-29-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (7)

Targets (1)