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/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 days 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.
Title
- Brief Title: 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
- 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
| Drug | Synonyms | Arms |
|---|
| ABBV-637 | | Part 1: ABBV-637 Monotherapy |
| Docetaxel | | Part 2a: ABBV-637 + Docetaxel |
| Osimertinib | | Part 3a: ABBV-637 + Osimertinib |
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/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 days 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1: ABBV-637 Monotherapy | Experimental | Participants will receive escalating doses of ABBV-637 in 28-day cycles. | |
| Part 2a: ABBV-637 + Docetaxel | Experimental | Participants will receive escalating doses of ABBV-637 in combination with docetaxel in 28-day cycles. | |
| Part 2b: ABBV-637 + Docetaxel | Experimental | Participants will receive ABBV-637 at dose determined in Part 2a in combination with docetaxel in 28-day cycles. | |
| Part 3a: ABBV-637 + Osimertinib | Experimental | Participants will receive escalating doses of ABBV-637 in combination with osimertinib in 28-day cycles. | |
| Part 3b: ABBV-637 + Osimertinib | Experimental | Participants will receive ABBV-637 at dose determined in Part 3a in combination with osimertinib in 28-day cycles. | |
Eligibility Criteria
Inclusion Criteria:
- Histologic solid tumor diagnosis (Part 1).
- Participants enrolled in Part 2 and Part 3(combination dose escalation and expansion)
must have non-small cell lung cancer (NSCLC) epidermal growth factor receptor
(EGFR)-expressing per central laboratory testing.
- 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 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.
| 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 2 & 3) |
| 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 2 & 3) |
| 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 2 & 3) |
| 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
- Osimertinib
Last Updated
July 30, 2021
