M21-410, Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab

JRCT ID: jRCT2031210386

Registered date:22/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma
• Date of first enrollment: 07/01/2021
• Target sample size: 176
• Countries of recruitment: United States,Japan,Israel,Japan
• Study type: Interventional

Intervention(s)

Experimental: Part 1 Dose Escalation: ABBV-514
Drug: ABBV-514, Intravenous (IV) Infusion

Experimental: Part 1 Dose Escalation: ABBV-514 + Budigalimab
Drug: ABBV-514, Intravenous (IV) Infusion
Drug: Budigalimab,IV Infusion, Other Name:ABBV-181

Experimental: Part 2 Dose Expansion: ABBV-514
Drug: ABBV-514, Intravenous (IV) Infusion

Experimental: Part 2 Dose Expansion: ABBV-514 + Budigalimab
Drug: ABBV-514, Intravenous (IV) Infusion
Drug: Budigalimab,IV Infusion, Other Name:ABBV-181

Experimental: Part 2 Dose Expansion: ABBV-514 + Budigalimab
Drug: ABBV-514, Intravenous (IV) Infusion
Drug: Budigalimab,IV Infusion, Other Name: ABBV-181

Outcome(s)

• Primary Outcome: Number of Participants with Adverse Events (AE) ,Maximum Observed Serum Concentration (Cmax) of ABBV-514, Maximum Observed Serum Concentration (Cmax) of of ABBV-154, Time to maximum Observed Serum Concentration (Tmax) of of ABBV-154, Terminal Elimination Half-Life (t1/2) of ABBV-514, Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514, Antidrug Antibody (ADA), Neutralizing Antidrug Antibody (ADA)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Dose-escalation cohorts only:
- Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.

Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
- Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy).
- Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease.

Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).

Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1.

Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.

Laboratory values meeting the criteria outlined in the protocol.

Exclude criteria

Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only:
- Non-Small Cell Lung Cancer (NSCLC) participants with known EGFR mutations or ALK gene rearrangements are ineligible.

Related Information

• Primary Sponsor: Okubo Sumiko
• Secondary ID(s): NCT05005403