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

Launched by ABBVIE · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two investigational drugs, ABBV-514 and Budigalimab, to see how they affect adults with advanced Non-Small Cell Lung Cancer (NSCLC) or Head and Neck Squamous Cell Carcinoma (HNSCC). The goal is to understand the safety of these treatments, how they work in the body, and to find the best dosage. About 268 adult participants will join the study at around 80 sites worldwide, receiving the drugs through an intravenous (IV) infusion for up to two years.

To be eligible, participants should have advanced solid tumors that have not responded to or are not suitable for standard treatments. This includes people with specific types of NSCLC or HNSCC who have already been treated with certain chemotherapy and targeted therapies. Throughout the trial, participants will have regular medical check-ups, including blood tests and assessments for side effects, to monitor how well the treatment is working. It's important to note that this trial may require more visits and monitoring compared to regular treatment, as the researchers aim to gather detailed information about the drugs being tested.

Gender

ALL

Eligibility criteria

• 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 is not suitable for surgical resection and / or radiation therapy and 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 \<= 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.