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OpenTrials
Completed

NCT Number: NCT02955251

A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
  • Participants have adequate bone marrow, renal, hepatic and coagulation function.
  • For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
  • Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.

Exclusion criteria

  • Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
  • History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
  • Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
  • Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.

Treatment and study plan

ABBV-428

Drug

ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

Nivolumab

Drug

Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Other names: OPDIVO

Primary outcomes

  1. Number of participants with adverse events

    Time frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose

  2. Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab

    Time frame: 1 day of study drug administration within the 28-day cycle at the designated cohort dose

    If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.

  3. Area under the serum concentration-time curve (AUC) of ABBV-428

    Time frame: Up to 30 days after a 24-month treatment period

  4. Terminal half-life (t1/2) of ABBV-428

    Time frame: Up to 30 days after a 24-month treatment period

  5. Maximum observed serum concentration (Cmax) of ABBV-428

    Time frame: Up to 30 days after a 24-month treatment period

  6. Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab

    Time frame: Up to 2 years

    The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

  7. Time to Cmax (Tmax) of ABBV-428

    Time frame: Up to 30 days after a 24-month treatment period

Secondary outcomes

  1. Duration of Objective Response (DOR)

    Time frame: Up to 30 days after a 24-month of treatment period

    DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  2. Clinical benefit rate (CBR)

    Time frame: Up to 30 days after a 24-month of treatment period

    CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.

  3. Progression-Free Survival (PFS)

    Time frame: Up to 30 days after a 24-month of treatment period

    PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first

  4. Objective Response Rate (ORR)

    Time frame: Up to 30 days after a 24-month of treatment period

    ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2016
Registry last updated
Jul 20, 2020

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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