Advanced Solid Tumors, Biliary Tract Cancer, Colorectal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Advanced Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Biliary Tract Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Cancer, ABBV-253
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events, change in disease activity and pharmacokinetics of ABBV-253. ABBV-253 is an investigational drug being developed for the treatment of advanced solid tumors. This open-label study consists of two parts. In Part 1 (ABBV-253 dose escalation), participants with any of the eligible cancer types will receive 1 of 4 (or more) doses of ABBV-253. Each cohort receives a higher dose, lower dose, or the same dose of ABBV-253 than the previous group. In Part 2 (ABBV-253 dose optimization), a new group of participants with NSCLC will be randomly put into pre-determined dose groups to receive 1 of 3 doses of ABBV-253. Approximately 130 participants will be enrolled in the study at approximately 11 sites worldwide. Participants will receive intravenous (IV) infusion of ABBV-253, as part of the 4 year study. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGABBV-253
Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Part 1 monotherapy dose escalation only: Participants with a diagnosis of a malignant solid tumor by histology (WHO criteria), including, but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), PDAC, gastroesophageal adenocarcinoma (GEA), ovarian cancer (OC), and biliary tract cancer (BTC) * ECOG performance status of 0 or 1 * Participants with evaluable and measurable disease per RECIST Version 1.1.
Exclusion criteria
* History of other malignancies, with the following exceptions: * No known active disease present within 3 years prior to first dose of study treatment and felt to be at low risk of recurrence by the treating investigator. * Adequately treated in situ carcinoma without evidence of disease. * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin without evidence of disease. * Participants with ovarian cancer with histologies other than high grade serous ovarian cancer including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor. * Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids or any evidence of ILD or pneumonitis on Screening chest CT scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to approximately 4 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. Safety will be evaluated based upon the assessment of all-grade AEs, and SAEs reported during the treatment-emergent period, as well as clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and ECG results. |
| Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements | Up to approximately 4 years | Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. |
| Number of Participants with Change from Baseline in Electrocardiogram (ECG) | Up to approximately 4 years | 12-lead resting ECG will be recorded. |
| Objective Response (OR) | Up to approximately 4 years | Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators. |
| Number of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results | Up to approximately 4 years | Number of participants with abnormal change in clinical laboratory test results like hematology and chemistry will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Anti-Drug Antibodies (ADAs) | Up to approximately 1 year | Incidence of Anti-Drug Antibodies (ADAs) |
| Incidence of Neutralizing Antibodies (nAbs) | Up to approximately 1 year | Incidence of Neutralizing Antibodies (nAbs) |
| Duration of Response (DOR) by Investigator | Up to approximately 4 years | Duration of response (DOR) is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. |
| Progression-Free Survival (PFS) by Investigator | Up to approximately 4 years | PFS per RECIST v1.1 as assessed by investigator, defined as the time from the first dose of study drug to the first documentation of disease progression or death from any cause. |
| Overall Survival (OS) | Up to approximately 4 years | Overall survival (OS) defined as the time from the first dose of study drug to death from any cause. |
| Disease Control (DC) by Investigator | Up to approximately 4 years | Disease Control (DC) defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR), or Stable Disease (SD) lasting at least 11 weeks following first study treatment, per investigator according to RECIST version 1.1. |
| Objective Response (OR) by Blinded Independent Central Review (BICR) | Up to approximately 4 years | Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators.. |
| Duration of Response (DOR) by BICR | Up to approximately 4 years | Duration of response (DOR) is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. |
| Progression-Free Survival (PFS) by BICR | Up to approximately 4 years | Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier. |
| Disease Control (DC) by BICR | Up to approximately 4 years | Disease Control (DC) is defined as best overall response of confirmed CR or confirmed PR, or SD lasting at least 11 weeks following first study treatment, according to RECIST version 1.1. |
| Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-253, ADC, total antibody, and payload | Up to approximately 1 year | Cmax of ABBV-253 ADC, total antibody, and payload |
| Time to Maximum Serum/Plasma Concentration (Tmax) of ABBV-253 | Up to approximately 1 year | Tmax of ABBV-253 |
| Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-253 ADC, total antibody, and payload | Up to approximately 1 year | AUC of ABBV-253 ADC, total antibody, and payload |
| Terminal Half-Life (t1/2) of ABBV-253 ADC, total antibody, and payload | Up to approximately 1 year | t1/2 of ABBV-253 ADC, total antibody, and payload |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed