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

NCT04196283 | Completed Phase 1 FDA Drug

• 2 other identifiers: M19-8942019-003167-22
• Study Type: interventional
• Target: 30
• Locations: 6 countries
• Sites: 26

Brief 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).

Conditions

Advanced Solid Tumors Cancer

Keywords

Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Locally Advanced Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma; Cancer

Outcome Measures

Primary Outcomes (18)

• 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

• 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

• 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

• 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)

• 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)

• 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)

• Terminal-Phase Elimination Rate Constant (β) of ABBV-368

  Terminal-Phase Elimination Rate Constant (β) of ABBV-368

  Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

• 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)

• Maximum Plasma Concentration (Cmax) of Tilsotolimod

  Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod

  Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

• 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)

• 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)

• Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

  Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

  Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

• 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)

• 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)

• 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)

• 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)

• Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)

  Terminal-Phase Elimination Rate Constant (β) of ABBV-181

  Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

• 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 Outcomes (5)

• Objective Response Rate (ORR)

  Up to approximately 2 years following the first dose

• Clinical Benefit Rate (CBR)

  Up to approximately 2 years following the first dose

• Time to Response (TTR)

  Up to approximately 2 years following the first dose

• Progression Free Survival (PFS)

  Up to approximately 2 years following the first dose

• Duration of Response (DOR)

  Up to approximately 2 years following the first dose

Study Arms (3)

Arm 1: ABBV-368 + Tilsotolimod

EXPERIMENTAL

Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.

Drug: ABBV-368; Drug: Tilsotolimod

Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel

EXPERIMENTAL

Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.

Drug: ABBV-368; Drug: Tilsotolimod; Drug: Nab-paclitaxel

Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

EXPERIMENTAL

Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.

Drug: ABBV-368; Drug: Tilsotolimod; Drug: Nab-paclitaxel; Drug: ABBV-181

Interventions

ABBV-368 DRUG

Intravenous (IV) infusion

Arm 1: ABBV-368 + Tilsotolimod; Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel; Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

Tilsotolimod DRUG

Intratumoral (IT) injection

Arm 1: ABBV-368 + Tilsotolimod; Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel; Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

Nab-paclitaxel DRUG

Intravenous (IV) infusion

Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel; Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

ABBV-181 DRUG

Intravenous (IV) infusion

Also known as: Budigalimab

Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead
• Idera Pharmaceuticals, Inc.: collaborator

Study Sites (26)

The University of Chicago Medical Center /ID# 217196

Chicago, Illinois, 60637-1443, United States

Location

Norton Cancer Institute /ID# 216179

Louisville, Kentucky, 40241-2832, United States

Location

Barbara Ann Karmanos Cancer In /ID# 214050

Detroit, Michigan, 48201, United States

Location

Nebraska Methodist Hospital /ID# 215786

Omaha, Nebraska, 68114, United States

Location

Atlantic Health System /ID# 216159

Morristown, New Jersey, 07960-6136, United States

Location

Roswell Park Comprehensive Cancer Center /ID# 215882

Buffalo, New York, 14263, United States

Location

Vanderbilt Ingram Cancer Center /ID# 214040

Nashville, Tennessee, 37232-0021, United States

Location

MD Anderson Cancer Center /ID# 214041

Houston, Texas, 77030, United States

Location

Centre Antoine Lacassagne - Nice /ID# 215706

Nice, Alpes-Maritimes, 06189, France

Location

AP-HM - Hopital de la Timone /ID# 215657

Marseille, Bouches-du-Rhone, 13385, France

Location

Hopital Saint-Andre /ID# 215702

Bordeaux, Gironde, 33075, France

Location

Institut Curie /ID# 215653

Paris, Île-de-France Region, 75248, France

Location

Universitaetsklinikum Erlangen /ID# 214196

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Leipzig /ID# 214200

Leipzig, Saxony, 04103, Germany

Location

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197

Berlin, 12203, Germany

Location

The Chaim Sheba Medical Center /ID# 215229

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Campus /ID# 215231

Haifa, 3109601, Israel

Location

Gastroenterology Institute, Division of Medicine /ID# 215862

Jerusalem, 91120, Israel

Location

Antoni van Leeuwenhoek /ID# 215291

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 221402

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario de Fuenlabrada /ID# 214263

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Clinic de Barcelona /ID# 214264

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre /ID# 214198

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 214110

Madrid, 28050, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 214109

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 221401

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms

Interventions

tilsotolimod; 130-nm albumin-bound paclitaxel; budigalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 12, 2019
• Study Start: January 22, 2020
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); IL (3); ES (7); NL (1); DE (3); FR (4)