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Advanced Solid Tumors CancerPhase 1NCT04196283

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

A Phase 1 study testing ABBV-368, Tilsotolimod and Nab-paclitaxel in people with Advanced Solid Tumors Cancer, run by AbbVie at 26 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
ABBV-368, Tilsotolimod and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
26 sitesin 6 countries
Study dates
22 Jan 2020to 27 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

26 sites in 6 countries.

26 sites in 6 countries

United States8 sites

  • Roswell Park Comprehensive Cancer Center /ID# 215882

    Buffalo, New York, 14263

  • The University of Chicago Medical Center /ID# 217196

    Chicago, Illinois, 60637-1443

  • Barbara Ann Karmanos Cancer In /ID# 214050

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center /ID# 214041

    Houston, Texas, 77030

  • Norton Cancer Institute /ID# 216179

    Louisville, Kentucky, 40241-2832

  • Atlantic Health System /ID# 216159

    Morristown, New Jersey, 07960-6136

  • Vanderbilt Ingram Cancer Center /ID# 214040

    Nashville, Tennessee, 37232-0021

  • Nebraska Methodist Hospital /ID# 215786

    Omaha, Nebraska, 68114

Other trials in United States

Spain7 sites

  • Hospital Clinic de Barcelona /ID# 214264

    Barcelona, 08036

  • Hospital Universitario de Fuenlabrada /ID# 214263

    Fuenlabrada, Madrid, 28942

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

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre /ID# 214198

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 214110

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria /ID# 214109

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia /ID# 221401

    Valencia, 46010

Other trials in Spain

France4 sites

  • Hopital Saint-Andre /ID# 215702

    Bordeaux, Gironde, 33075

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

    Marseille, Bouches-du-Rhone, 13385

  • Centre Antoine Lacassagne - Nice /ID# 215706

    Nice, Alpes-Maritimes, 06189

  • Institut Curie /ID# 215653

    Paris, Île-de-France Region, 75248

Other trials in France

Germany3 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197

    Berlin, 12203

  • Universitaetsklinikum Erlangen /ID# 214196

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Leipzig /ID# 214200

    Leipzig, Saxony, 04103

Other trials in Germany

Israel3 sites

  • Rambam Health Care Campus /ID# 215231

    Haifa, 3109601

  • Gastroenterology Institute, Division of Medicine /ID# 215862

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 215229

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Netherlands1 site

  • Antoni van Leeuwenhoek /ID# 215291

    Amsterdam, North Holland, 1066 CX

Other trials in Netherlands

About this study

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

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).

Being tested
ABBV-368, Tilsotolimod, Nab-paclitaxel, ABBV-181
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
Medical subject headings
Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-368Drug

    Intravenous (IV) infusion

  • TilsotolimodDrug

    Intratumoral (IT) injection

  • Nab-paclitaxelDrug

    Intravenous (IV) infusion

  • ABBV-181Drug

    Also called Budigalimab

    Intravenous (IV) infusion

Study groups in NCT04196283
Study groupRoleWhat they receive
Arm 1: ABBV-368 + TilsotolimodExperimentalParticipants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
Receives: Drug: ABBV-368; Drug: Tilsotolimod
Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxelExperimentalParticipants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
Receives: Drug: ABBV-368; Drug: Tilsotolimod; Drug: Nab-paclitaxel
Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181ExperimentalParticipants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
Receives: Drug: ABBV-368; Drug: Tilsotolimod; Drug: Nab-paclitaxel; Drug: ABBV-181

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 2 years following the first dose

  2. 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.

    Measured: Up to approximately 2 years following the first dose

  3. 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.

    Measured: Up to approximately 2 years following the first dose

  4. Maximum Observed Serum Concentration (Cmax) of ABBV-368

    Maximum Serum Concentration (Cmax) of ABBV-368

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

  5. Time to Maximum Serum Concentration (Tmax) of ABBV-368

    Time to Maximum Serum Concentration (Tmax) of ABBV-368

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

  6. 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)

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

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

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

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

  8. Terminal Half-Life (t1/2) of ABBV-368

    Terminal Half-Life (t1/2) of ABBV-368

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

  9. Maximum Plasma Concentration (Cmax) of Tilsotolimod

    Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod

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

  10. Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod

    Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod

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

  11. 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)

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

  12. Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

    Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod

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

  13. Terminal Half-Life (t1/2) of Tilsotolimod

    Terminal Half-Life (t1/2) of Tilsotolimod

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

  14. Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)

    Maximum Observed Serum Concentration (Cmax) of ABBV-181

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

  15. Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)

    Time to Maximum Serum Concentration (Tmax) of ABBV-181

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

  16. 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)

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

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

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

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

  18. Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)

    Terminal Half-Life (t1/2) of ABBV-181

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

Secondary outcomes (5)

  1. 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.

    Measured: Up to approximately 2 years following the first dose

  2. 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)

    Measured: Up to approximately 2 years following the first dose

  3. 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.

    Measured: Up to approximately 2 years following the first dose

  4. Progression Free Survival (PFS)

    PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first.

    Measured: Up to approximately 2 years following the first dose

  5. 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.

    Measured: Up to approximately 2 years following the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2019
  2. Study start22 Jan 2020
  3. Primary completion27 Oct 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04196283
Sponsor's protocol ID
M19-894
Other IDs
2019-003167-22, 2019
Status last verified
Feb 2023
First submitted
6 Dec 2019
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Daste A, Le X, Makkouk A, Patel M, Le Tourneau C, Perets R, Popovtzer A, Ochsenreither S, Haderlein M, Oliva M, Sukari A, Hong J, Blaney M, Ramathal C, McDevitt M, Rosenberg AJ. Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma. J Immunother Cancer. 2026 Apr 9;14(4):e014086. doi: 10.1136/jitc-2025-014086.

    PubMed 41956545

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-368, Tilsotolimod and Nab-paclitaxel in people with Advanced Solid Tumors Cancer, run by AbbVie at 26 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Spain, France, Germany, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 2 years following the first dose). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04196283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.

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