To assess safety, tolerability, and PK of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and Budigalimab in subjects with R/M HNSCC.
ID
Source
Brief title
Condition
- Plasma cell neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Safety evaluations include AE monitoring, physical examinations, vital sign
measurements, and clinical laboratory testing (hematology, chemistry, and
urinalysis) as measures of safety and tolerability for the entire study
duration.
- Blood samples to assess serum concentrations of ABBV-368 and budigalimab and
plasma concentrations of tilsotolimod will be obtained at the visits indicated
in the Activity Schedule
The following PK parameters will be determined for ABBV-368, tilsotolimod and
budigalimab (if applicable) after infusion between Cycle 1 to Cycle 3 using
noncompartmental methods, as applicable based on data availability of the
individual compounds:
• maximum observed serum/plasma concentration (Cmax)
• time to Cmax (Tmax)
• area under the serum/plasma concentration versus time curve from time 0 to
the time of the last measurable concentration (AUC*)
• terminal-phase elimination rate constant (β); and terminal half-life (t1/2)
• additional parameters may be calculated if useful in the interpretation of
the PK data. The immunogenicity of tilsotolimod, ABBV-368, and budigalimab will
be assessed to aid in the interpretation of PK data.
Secondary outcome
Efficacy endpoints based on RECIST, v1.1:
- Objective response rate (ORR): the proportion of subjects with CR or PR as a
confirmed response
- Clinical benefit rate (CBR): the proportion of subjects with a confirmed CR,
confirmed PR, or SD
- Time to response (TTR): among subjects who responded, TTR is the time from
date of first study drug exposure to the first instance of a CR or PR as a
confirmed response, whichever occurs first
- Progression free survival (PFS): the time from date of first study drug
exposure to disease progression or death, whichever occurs first
- Duration of response (DOR): the time from the subject's initial response (CR
or PR as a confirmed response) to disease progression or death, whichever
occurs first
Background summary
Head and neck squamous cell carcinoma (HNSCC) is one of the most common type of
cancers worldwide. People over age 50 are most vulnerable, particularly those
who use tobacco. HNSCC can occur in areas including the mouth, throat, or
voice box. The cancer can cause patches or open sores (ulcers) in the
mouth/throat, bleeding/pain, sore throat, pain or difficulty when swallowing,
hoarse voice, difficulty breathing or enlarged lymph nodes.
Study objective
To assess safety, tolerability, and PK of ABBV-368 plus tilsotolimod; ABBV-368
plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod,
nab-paclitaxel, and Budigalimab in subjects with R/M HNSCC.
Study design
Non-Randomized, open-label, sequential assignment.
Intervention
There are 3 arms to the study - Arm 1, Arm 2, and Arm 3. Participants will be
placed in one of the following arms:
• Arm 1: ABBV-368 + tilsotolimod
• Arm 2: ABBV-368 + tilsotolimod + nab-paclitaxel
• Arm 3: ABBV-368 + tilsotolimod + nab-paclitaxel + ABBV-181
Study burden and risks
The effect of treatment on the disease will be checked by performing diagnostic
imaging, blood tests, and tissue collection (some optional). Safety evaluations
will occur throughout the study and will include blood and urine tests,
electrocardiogram (ECG), and physical exams.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years old and weigh at least 35 kg
- Eastern Cooperative Oncology Group performance status of 0 or 1 and a life
expectancy of >= 3 months
- Have >= 1 lesion accessible for intratumoral injection and lesion(s) must be >=
2 cm in longest diameter.
- 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 (either in the definitive or
advanced, recurrent/metastatic setting), or be considered ineligible for
platinum-based therapy by the investigator.
Exclusion criteria
- No uncontrolled metastases to the central nervous system (CNS). Subjects 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 subjects have not used prohibited levels of steroids for at least 4
weeks prior to first dose of the study.
- Must not have received prior treatment with OX40 or TLR agonists (excluding
topical agents)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003167-22-NL |
| ClinicalTrials.gov | NCT04196283 |
| CCMO | NL72205.056.20 |