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

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ClinicalTrials.gov Identifier: NCT04721015
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

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/osimertinib 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 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 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 IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.

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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Non Small Cell Lung Cancer (NSCLC) Drug: ABBV-637 Drug: Docetaxel Drug: Osimertinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : November 28, 2026
Estimated Study Completion Date : November 28, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: ABBV-637 Monotherapy
Participants will receive escalating doses of ABBV-637 in 28-day cycles.
 Drug: ABBV-637
Intravenous (IV) Infusion
Experimental: Part 2a: ABBV-637 + Docetaxel
Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles.
 Drug: ABBV-637
Intravenous (IV) Infusion

Drug: Docetaxel
Intravenous (IV) Infusion
Experimental: Part 2b: ABBV-637 + Docetaxel
Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles.
 Drug: ABBV-637
Intravenous (IV) Infusion

Drug: Docetaxel
Intravenous (IV) Infusion
Experimental: Part 3a: ABBV-637 + Osimertinib
Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles.
 Drug: ABBV-637
Intravenous (IV) Infusion

Drug: Osimertinib
Oral Tablets
Experimental: Part 3b: ABBV-637 + Osimertinib
Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles.
 Drug: ABBV-637
Intravenous (IV) Infusion

Drug: Osimertinib
Oral Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Percentage of Participants With Objective Response Rate (ORR) (Part 2 & 3) [ Time Frame: Up to approximately 3 years ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Objective Response Rate (ORR) (Part 1) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Duration of Response (DOR) for ABBV-637 Administered as Monotherapy (Part 1) [ Time Frame: Up to approximately 12 months ]
    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.

  3. Duration of Response (DOR) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [ Time Frame: Up to approximately 20 months ]
    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.

  4. Progression-Free Survival (PFS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [ Time Frame: Up to approximately 20 months ]
    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.

  5. Overall Survival (OS) for ABBV-637 in Combination With Docetaxel and Osimertinib (Part 2 & 3) [ Time Frame: Up to approximately 12 months after last dose of study drug ]
    OS is defined as the time from the first dose of any study drug until death from any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic solid tumor diagnosis (Part 1).
  • For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
  • For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
  • 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 R/R disease that has progressed on all standard of care therapy.
  • For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
  • For Part 3 only - history of RR NSCLC that has progressed on osimertinib
  • 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.
  • For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721015


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04721015    
Other Study ID Numbers: M20-111
2020-004953-57 ( EudraCT Number )
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Advanced Solid Tumors Cancer
Non Small Cell Lung Cancer
NSCLC
Cancer
 ABBV-637
Docetaxel
Osimertinib
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Docetaxel
Osimertinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors