Clinical Trials /

Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors

NCT04721015

Description:

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 2 parts - monotherapy dose escalation (Part 1) and combination dose escalation and expansion (Parts 2a and 2b). Approximately 60 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 25 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive intravenous (IV) ABBV-637 in combination with IV docetaxel in 28-day cycles. 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 a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors
  • Official Title: A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: M20-111
  • SECONDARY ID: 2020-004953-57
  • NCT ID: NCT04721015

Conditions

  • Advanced Solid Tumors Cancer
  • Non Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
ABBV-637Part 1: ABBV-637 Monotherapy
DocetaxelPart 2a: ABBV-637 + Docetaxel

Purpose

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed. ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 2 parts - monotherapy dose escalation (Part 1) and combination dose escalation and expansion (Parts 2a and 2b). Approximately 60 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 25 sites across the world. In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive intravenous (IV) ABBV-637 in combination with IV docetaxel in 28-day cycles. 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 a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

Trial Arms

NameTypeDescriptionInterventions
Part 1: ABBV-637 MonotherapyExperimentalParticipants will receive escalating doses of ABBV-637 in 28-day cycles.
  • ABBV-637
Part 2a: ABBV-637 + DocetaxelExperimentalParticipants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
  • ABBV-637
  • Docetaxel
Part 2b: ABBV-637 + DocetaxelExperimentalParticipants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
  • ABBV-637
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Histologic solid tumor diagnosis (Part 1).

          -  Participants enrolled in Part 2 (combination dose escalation and expansion) must have
             non-small cell lung cancer (NSCLC) epidermal growth factor receptor (EGFR)-expressing
             per central laboratory testing for Part 2b.

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  For Part 1 only - history of relapsed/refractory (R/R) disease that has progressed on
             all standard of care therapy.

          -  For Part 2 only - history of R/R NSCLC that has progressed after treatment with
             platinum-based chemotherapy doublet and either immune checkpoint inhibitor or targeted
             therapy and may not have been treated with prior single agent chemotherapy.

          -  Meet the laboratory values as described in the protocol.

        Exclusion Criteria:

          -  History (within 6 months) of congestive heart failure (defined as New York Heart
             Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia
             requiring pharmacological or surgical intervention, pericardial effusion, or
             pericarditis.

          -  Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except
             alopecia.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants Experiencing Adverse Events (AEs)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Secondary Outcome Measures

Measure:Percentage of Participants With Objective Response Rate (ORR) (Part 1)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:ORR is defined as the percentage of participants with a confirmed response (CR) or partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measure:Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1)
Time Frame:Up to approximately 12 months
Safety Issue:
Description:DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Measure:Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel (Part 2b)
Time Frame:Up to approximately 20 months
Safety Issue:
Description:DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Measure:Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel (Part 2b)
Time Frame:Up to approximately 20 months
Safety Issue:
Description:PFS is defined as the time from the first dose of any study drug to a documented radiographic disease progression according to RECIST version 1.1 as determined by the investigator, clinical progression or death from any cause, whichever occurs earlier.
Measure:Overall Survival (OS) for ABBV-637 in Combination With Docetaxel (Part 2b)
Time Frame:Up to approximately 12 months after last dose of study drug
Safety Issue:
Description:OS is defined as the time from the first dose of any study drug until death from any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Advanced Solid Tumors Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • Cancer
  • ABBV-637
  • Docetaxel

Last Updated

May 28, 2021