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NCT Number: NCT04721015

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Solid Tumors Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer (NSCLC) Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wollongong Hospital /ID# 228350, Wollongong, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ABBV-637

Drug

Intravenous (IV) Infusion

docetaxel

Drug

Intravenous (IV) Infusion

Osimertinib

Drug

Oral Tablets

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2021
Registry last updated
Jul 3, 2025

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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