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

Phase 1

Recruiting

• Conditions: on-Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma

• Registration Number: JPRN-jRCT2031210386
• Lead Sponsor: Okubo Sumiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 176

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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)