Description:
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).
Title
- Brief Title: 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
- 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 IDs
- ORG STUDY ID:
M19-894
- SECONDARY ID:
2019-003167-22
- NCT ID:
NCT04196283
Conditions
- Advanced Solid Tumors Cancer
Interventions
Drug | Synonyms | Arms |
---|
ABBV-368 | | Arm 1: ABBV-368 + Tilsotolimod |
Tilsotolimod | | Arm 1: ABBV-368 + Tilsotolimod |
Nab-paclitaxel | | Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel |
ABBV-181 | Budigalimab | Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1: ABBV-368 + Tilsotolimod | Experimental | Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol. | |
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. | - ABBV-368
- Tilsotolimod
- 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. | - ABBV-368
- Tilsotolimod
- Nab-paclitaxel
- ABBV-181
|
Eligibility Criteria
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants with Adverse Events (AEs) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | ORR is measured as the percentage of participants with a complete response (CR) or partial response (PR) as a confirmed response. |
Measure: | Clinical Benefit Rate (CBR) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | CBR is measured as the percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) |
Measure: | Time to Response (TTR) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | 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. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | PFS is the time from date of first study drug exposure to disease progression or death, whichever occurs first. |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to approximately 2 years following the first dose |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AbbVie |
Trial 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
Last Updated
July 29, 2021