A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Advanced Solid Tumors Cancer Clinical Trial

Official title:

A Phase 1b, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196283
• Other study ID #: M19-894
• Secondary ID: 2019-003167-22
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2020
• Est. completion date: October 27, 2022

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants should weigh at least 35 kg.

• Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of >= 3 months.

• Participant have >= 1 lesion accessible for intratumoral injection.

• Histologically or cytologically confirmed R/M HNSCC (of the following 4 subsites: oral cavity, oropharynx, larynx, and hypopharynx) who previously progressed either during or after <= 3 prior treatment regimens administered in the recurrent or metastatic setting.

• Must have received 1 immunotherapy regimen which included a PD-(L)1 inhibitor.

• Must have received platinum-based therapy, or be considered ineligible for platinum-based therapy by the investigator.

Exclusion Criteria:

• Uncontrolled metastases to the central nervous system (CNS).

• Participants with brain metastases are eligible provided that evidence of clinical and radiographic stable disease for at least 4 weeks after definitive therapy is given and participants have not used prohibited levels of steroids for at least 4 weeks prior to first dose of the study.

• Received prior treatment with OX40 or toll-like receptor (TLR) agonists (excluding topical agents).

Related Conditions & MeSH terms

• Advanced Solid Tumors Cancer
• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• ABBV-368
Intravenous (IV) infusion
• Tilsotolimod
Intratumoral (IT) injection
• Nab-paclitaxel
Intravenous (IV) infusion
• ABBV-181
Intravenous (IV) infusion

Locations

Country	Name	City	State
France	Hopital Saint-Andre /ID# 215702	Bordeaux	Gironde
France	AP-HM - Hopital de la Timone /ID# 215657	Marseille CEDEX 05	Bouches-du-Rhone
France	Centre Antoine Lacassagne - Nice /ID# 215706	Nice	Alpes-Maritimes
France	Institut Curie /ID# 215653	Paris CEDEX 05	Ile-de-France
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197	Berlin
Germany	Universitaetsklinikum Erlangen /ID# 214196	Erlangen	Bayern
Germany	Universitaetsklinikum Leipzig /ID# 214200	Leipzig	Sachsen
Israel	Rambam Health Care Campus /ID# 215231	Haifa
Israel	Gastroenterology Institute, Division of Medicine /ID# 215862	Jerusalem
Israel	The Chaim Sheba Medical Center /ID# 215229	Ramat Gan	Tel-Aviv
Netherlands	Antoni van Leeuwenhoek /ID# 215291	Amsterdam	Noord-Holland
Spain	Hospital Clinic de Barcelona /ID# 214264	Barcelona
Spain	Hospital Universitario de Fuenlabrada /ID# 214263	Fuenlabrada	Madrid
Spain	Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre /ID# 214198	Madrid
Spain	Hospital Universitario HM Sanchinarro /ID# 214110	Madrid
Spain	Hospital Universitario Virgen de la Victoria /ID# 214109	Malaga
Spain	Hospital Clinico Universitario de Valencia /ID# 221401	Valencia
United States	Roswell Park Comprehensive Cancer Center /ID# 215882	Buffalo	New York
United States	The University of Chicago Medical Center /ID# 217196	Chicago	Illinois
United States	Barbara Ann Karmanos Cancer In /ID# 214050	Detroit	Michigan
United States	MD Anderson Cancer Center /ID# 214041	Houston	Texas
United States	Norton Cancer Institute /ID# 216179	Louisville	Kentucky
United States	Atlantic Health System /ID# 216159	Morristown	New Jersey
United States	Vanderbilt Ingram Cancer Center /ID# 214040	Nashville	Tennessee
United States	Nebraska Methodist Hospital /ID# 215786	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Idera Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Israel,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 2 years following the first dose
Primary	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.	Up to approximately 2 years following the first dose
Primary	Change in Clinical Laboratory Test Results	Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.	Up to approximately 2 years following the first dose
Primary	Maximum Observed Serum Concentration (Cmax) of ABBV-368	Maximum Serum Concentration (Cmax) of ABBV-368	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Time to Maximum Serum Concentration (Tmax) of ABBV-368	Time to Maximum Serum Concentration (Tmax) of ABBV-368	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)	Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal-Phase Elimination Rate Constant (ß) of ABBV-368	Terminal-Phase Elimination Rate Constant (ß) of ABBV-368	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal Half-Life (t1/2) of ABBV-368	Terminal Half-Life (t1/2) of ABBV-368	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Maximum Plasma Concentration (Cmax) of Tilsotolimod	Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod	Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)	Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal-Phase Elimination Rate Constant (ß) of Tilsotolimod	Terminal-Phase Elimination Rate Constant (ß) of Tilsotolimod	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal Half-Life (t1/2) of Tilsotolimod	Terminal Half-Life (t1/2) of Tilsotolimod	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)	Maximum Observed Serum Concentration (Cmax) of ABBV-181	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)	Time to Maximum Serum Concentration (Tmax) of ABBV-181	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)	Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal-Phase Elimination Rate Constant (ß) of ABBV-181 (Arm 3 Only)	Terminal-Phase Elimination Rate Constant (ß) of ABBV-181	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Primary	Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)	Terminal Half-Life (t1/2) of ABBV-181	Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Secondary	Objective Response Rate (ORR)	ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response.	Up to approximately 2 years following the first dose
Secondary	Clinical Benefit Rate (CBR)	CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD)	Up to approximately 2 years following the first dose
Secondary	Time to Response (TTR)	TTR is the time from date of first study drug exposure to the first instance of a complete response (CR) or partial response (PR) as a confirmed response, whichever occurs first.	Up to approximately 2 years following the first dose
Secondary	Progression Free Survival (PFS)	PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.	Up to approximately 2 years following the first dose
Secondary	Duration of Response (DOR)	DOR is the time from the participant's initial response (CR or PR as a confirmed response) to disease progression or death, whichever occurs first.	Up to approximately 2 years following the first dose