[M24-122] A Study of Adverse Events, How Intravenously (IV) Infused ABBV-303 Moves Through the Body, and Change in Disease State, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adult Participants With Advanced Solid Tumors

JRCT ID: jRCT2031230705

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid Tumors
• Date of first enrollment: 15/03/2024
• Target sample size: 181
• Countries of recruitment: United states,Japan,Israel,Japan
• Study type: Interventional

Intervention(s)

Drug: ABBV-303 IV Infusion
Drug: Budigalimab IV Infusion, other name: ABBV-181

Outcome(s)

• Primary Outcome: - Percentage of Participants With Adverse Events (AE)

Secondary Outcome

- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
- Progression-free survival (PFS)
- Overall survival (OS)
- ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)

Key inclusion & exclusion criteria

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

Include criteria

- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug.
- Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization [WHO] criteria).
- Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Exclude criteria

- Unresolved Grade > 1 AEs from prior anti-cancer therapy except for alopecia.
- Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy.
- History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181).
- Body weight < 35 kg.

Related Information

• Primary Sponsor: Yamagishi Chika
• Secondary ID(s): NCT06158958