Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the white blood cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine recommended phase 2 dose (RP2D) and to see if the study drug is safe and able to treat patients who have AML and NSCLC. ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries. Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time. There will be a 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. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Intravenous (IV) infusion
Fort Wayne Medical Oncology and Hematology, Inc /ID# 224332
Fort Wayne, Indiana, United States
Gabrail Cancer Center Research /ID# 215667
Canton, Ohio, United States
Thomas Jefferson University /ID# 218403
Philadelphia, Pennsylvania, United States
Centre Antoine Lacassagne - Nice /ID# 218014
Nice, Alpes-Maritimes, France
CHU Bordeaux - Hopital Haut Leveque /ID# 224998
Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 217508
Lille, Hauts-de-France, France
CHU de Nantes, Hotel Dieu -HME /ID# 215703
Nantes, Pays de la Loire Region, France
Hopital Saint-Andre /ID# 224218
Bordeaux, France
The Chaim Sheba Medical Center /ID# 215810
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 222749
Tel Aviv, Tel Aviv, Israel
...and 7 more locations
Recommended Phase 2 Dose (RP2D) of ABBV-184 (Dose-Escalation Phase)
The RP2D of ABBV-184 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
Time frame: Up to 1 Cycle after the last participant is enrolled in dose escalation phase (Approximately 2 years)
Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) Rate (Dose Expansion Phase in Participants With AML)
CR/CRh rate is assessed based on the Clopper-Pearson (exact) method.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Objective Response Rate (ORR) (Dose Expansion Phase in Participants With NSCLC)
ORR is defined as participants with confirmed complete or partial response (CR+PR) per RECIST, v1.1
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Number of Participants with Adverse Events (AEs)
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. 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.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Laboratory Parameters
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Vital Signs
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a one page 30-point written test that assesses cognitive function.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Echocardiogram
Number of participants with abnormal change from baseline in echocardiogram will be reported.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Electrocardiogram (ECG)
12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Maximum Observed Serum Concentration (Cmax) of ABBV-184
Maximum Serum Concentration (Cmax) of ABBV-184.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Time to Maximum Observed Serum Concentration (Tmax)
Time to Maximum Serum Concentration (Tmax) of ABBV-184.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Terminal Phase Elimination Rate Constant (β) for ABBV-184
Terminal Phase Elimination Rate Constant (β) for ABBV-184.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Terminal Phase Elimination Half-life (t1/2) of ABBV-184
Terminal Phase Elimination Half-life (t1/2) of ABBV-184.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Area Under the Serum Concentration-Time Curve of ABBV-184
Area Under the Serum Concentration-Time Curve of ABBV-184.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Percentage of Participants With Anti-drug Antibodies (ADAs)
Percentage of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Duration of Response (DOR) (Dose Expansion Phase)
DOR is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever occurs first.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Progression-free Survival (PFS) (Dose Expansion Phase)
PFS will be defined as the time between the first dose of any study drug and the first occurrence of progression or death from any cause.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Relapse-Free Survival (RFS) (Dose Expansion Phase in Participants With AML)
RFS is defined as the time between date of first response and the first occurrence of progression or death from any cause, whichever occurs first.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Bone Marrow Blast Count (Dose Expansion Phase in Participants With AML)
Percentage of blast cells in bone marrow.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Change in Peripheral Blood Blast Count (Dose Expansion Phase in Participants With AML)
Percentage of blast cells in peripheral blood.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Objective Response Rate (ORR) (Dose Expansion Phase in Participants With AML)
ORR is defined as the proportion of participants with complete remission (CR), morphologic complete remission with incomplete blood count recovery (CRi), complete remission with partial hematologic recovery (CRh), complete response with incomplete platelet recovery (CRp), and partial remission (PR).
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Rate of Conversion to Transfusion Independence (Dose Expansion Phase in Participants With AML)
AML participants will be considered to have converted to transfusion independence if they receive no red blood cell transfusion, platelet transfusion, or growth factors for a 56-day window after beginning study treatment.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
Clinical Benefit Rate (CBR) (Dose Expansion Phase in Participants With NSCLC)
CBR is defined as the proportion of participants with a CR, PR, or stable disease (SD) for at least 6 weeks by RECIST 1.1 criteria.
Time frame: Up to 30 days after last participant complete study drug (Approximately 3 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.