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
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04721015 |
|
Recruitment Status :
Active, not recruiting
First Posted : January 22, 2021
Last Update Posted : October 17, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 81 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 : | February 29, 2024 |
| Estimated Study Completion Date : | February 29, 2024 |
| 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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
Show 33 study locations
| Study Director: | ABBVIE INC. | AbbVie |
| 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: | October 17, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
|
Advanced Solid Tumors Cancer Non Small Cell Lung Cancer NSCLC Cancer |
ABBV-637 Docetaxel Osimertinib |
|
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 Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |