Clinical trial

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

ID

Name

M19-894

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).

Trial arms

Trial start

2020-01-22

Estimated PCD

2022-10-27

Trial end

2022-10-27

Status

Completed

Phase

Early phase I

Treatment

ABBV-368

Intravenous (IV) infusion

Arms:

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

Tilsotolimod

Intratumoral (IT) injection

Arms:

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

Nab-paclitaxel

Intravenous (IV) infusion

Arms:

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

ABBV-181

Intravenous (IV) infusion

Arms:

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

Other names:

Budigalimab

Size

30

Primary endpoint

Number of Participants with Adverse Events (AEs)

Up to approximately 2 years following the first dose

Change in Vital Signs

Up to approximately 2 years following the first dose

Change in Clinical Laboratory Test Results

Up to approximately 2 years following the first dose

Maximum Observed 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

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)

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

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

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

Maximum Plasma Concentration (Cmax) of Tilsotolimod

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

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)

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

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

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

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

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

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

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)

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

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

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

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

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

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

Updated at

2023-02-27

1 organization

4 products

1 indication

Product

Indication

Advanced Solid Tumors

Product

Organization

Product

Product