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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03071757
Other study ID # M16-074
Secondary ID 2016-004205-14
Status Completed
Phase Phase 1
First received
Last updated
Start date March 21, 2017
Est. completion date April 13, 2022

Study information

Verified date April 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.


Description:

Recruitment is closed in Part 1A; subjects are in maintenance


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date April 13, 2022
Est. primary completion date April 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have histologic or cytology diagnosis of a known immunogenic solid tumor, as described for Part 1 Dose Escalation and Part 2 Cohort Expansion: - Part 1 Dose Escalation: - Participants with advanced or metastatic solid tumors that have exhausted standard treatment for their incurable disease and for whom there is currently no programmed cell death 1 (PD-1)/ programmed cell death-ligand 1 (PD-L1) approved therapy, with immunogenic type tumors such as, but not limited to triple negative breast cancer (TNBC), ovarian cancer, small cell lung cancer, mesothelioma, and cholangiocarcinoma. - Participants who are refractory to a PD-1/PD-L1 agent, with tumor types such as melanoma, NSCLC, platinum-pretreated head and neck cancer, second line bladder and RCC. - Part 2A and 2B Cohort Expansion: - 2A : TNBC ABBV-368 monotherapy cohorts: Subjects with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease. - 2B : Head and Neck cohort: Participants with recurrent squamous cell head and neck carcinoma that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. - Part 3A and 3B Imaging Substudy: - 3A: Participants with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease and are treatment naïve to a PD-1/PD-L1 targeting agent. - 3B: Participants with recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. Participants must be treatment naïve to a PD-1/PD-L1 targeting agent. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2. - Participants must have immune-related Response Evaluation Criteria for Solid Tumors (iRECIST) evaluable or measurable disease in the PART 1 and measurable disease per iRECIST in PART 2 - Adequate bone marrow, kidney and liver function. Exclusion Criteria: - Received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 21 days prior to the first dose of ABBV-368. - Prior treatment with an OX40 targeting agent. - has known uncontrolled metastases to the central nervous system (CNS). - History of active autoimmune disorders and other conditions that compromise or impair the immune system. - Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active hepatitis A, B or C. Subjects who have a history of hepatitis B or C who have documented cures after anti-viral therapy may be enrolled. - Has received live vaccine within 28 days prior to the first dose of study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABBV-368
Intravenous infusion
ABBV-181
Intravenous infusion

Locations

Country Name City State
France Centre Leon Berard /ID# 165037 Lyon CEDEX 08 Rhone
France AP-HM - Hopital de la Timone /ID# 165036 Marseille CEDEX 05 Bouches-du-Rhone
France Institut Curie /ID# 165038 Paris CEDEX 05 Ile-de-France
France Institut Gustave Roussy /ID# 165035 Villejuif Cedex Val-de-Marne
Japan National Cancer Center Hospital /ID# 214531 Chuo-ku Tokyo
Japan National Cancer Center Hospital East /ID# 214530 Kashiwa-shi Chiba
Puerto Rico Pan American Center for Oncology Trials, LLC /ID# 213809 Rio Piedras
Spain Hospital Duran i Reynals /ID# 205997 Hospitalet de Llobregat Barcelona
Spain CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996 Madrid
Spain Hospital General Universitario Gregorio Maranon /ID# 205999 Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz /ID# 211500 Madrid
Spain Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973 Majadahonda Madrid
Spain CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879 Pamplona Navarra
Spain Hospital Clinico Universitario de Valencia /ID# 211499 Valencia
Taiwan National Cheng Kung University Hospital /ID# 164002 Tainan
Taiwan National Taiwan University Hospital /ID# 164000 Taipei City
Taiwan Taipei Medical University Hospital /ID# 164001 Taipei City
United States University of Virginia /ID# 212895 Charlottesville Virginia
United States University of Texas Southwestern Medical Center /ID# 201934 Dallas Texas
United States Virginia Cancer Specialists - Fairfax /ID# 160787 Fairfax Virginia
United States Greenville Hospital System /ID# 160785 Greenville South Carolina
United States Carolina BioOncology Institute /ID# 160786 Huntersville North Carolina
United States Moores Cancer Center at UC San Diego /ID# 201334 La Jolla California
United States Yale University /ID# 207895 New Haven Connecticut
United States University of California, Davis Comprehensive Cancer Center /ID# 201342 Sacramento California
United States South Texas Accelerated Research Therapeutics /ID# 160788 San Antonio Texas
United States Stanford University /ID# 206949 Stanford California

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  France,  Japan,  Puerto Rico,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Terminal half-life (t1/2) of ABBV-368 Terminal half-life of ABBV-368 Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Primary Area under the serum concentration-time curve (AUC) of ABBV-368 Area under the serum concentration-time curve of ABBV-368 Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Primary Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with ABBV-181 The MTD of ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Up to 1 year
Primary Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be established during the Dose expansion of the study Up to 18 months
Primary Time to Cmax (Tmax) of ABBV-368 Time to Cmax of ABBV-368 Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Primary Terminal phase elimination rate constant (ß) of ABBV-368 Terminal phase elimination rate constant of ABBV-368 Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Primary Number of Participants With Adverse Events An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Primary Maximum observed serum concentration (Cmax) of ABBV-368 Maximum observed serum concentration of ABBV-368 Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Secondary Objective Response Rate (ORR) ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Secondary Clinical benefit rate (CBR) CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease. Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Secondary Duration of Objective Response (DOR) DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first. Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
Secondary Progression-Free Survival (PFS) PFS time is defined as the time from the first dose of study drug (Day 1) to disease progression or death, whichever occurs first. Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination
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