Assessing a new treatment for advanced solid tumors

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors

This study is testing a new drug called ABBV-303, alone and with another drug, to see if it helps adults with advanced solid tumors like lung and kidney cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (industry)
• Drugs / interventions: budigalimab
• Locations: 18 sites (Duarte, California and 17 other locations)
• Trial ID: NCT06158958 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, pharmacokinetics, and efficacy of ABBV-303, an investigational drug, both alone and in combination with another investigational drug, budigalimab, in adults with advanced solid tumors. Participants will receive intravenous infusions of ABBV-303 at escalating doses, either as a monotherapy or in combination with budigalimab. The study aims to enroll approximately 181 adult participants with various types of relapsed or refractory solid tumors, including non-small cell lung cancer and renal cell carcinoma. The study will assess how well these treatments work and their safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory solid tumors who meet specific health criteria.

Not a fit: Patients with unresolved adverse events from prior therapies or those with certain infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies have explored similar combinations of investigational drugs, but the specific approach of this study is novel.

Eligibility criteria

Inclusion 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).

Exclusion Criteria:

* Unresolved Grade \> 1 adverse events (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.

Where this trial is running

Duarte, California and 17 other locations

• City of Hope /ID# 254303 — Duarte, California, United States (RECRUITING)
• City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792 — Irvine, California, United States (RECRUITING)
• University of Southern California /ID# 254356 — Los Angeles, California, United States (RECRUITING)
• START Midwest /ID# 256945 — Grand Rapids, Michigan, United States (RECRUITING)
• Washington University-School of Medicine /ID# 262943 — Saint Louis, Missouri, United States (RECRUITING)
• NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943 — New York, New York, United States (RECRUITING)
• Carolina BioOncology Institute /ID# 254305 — Huntersville, North Carolina, United States (RECRUITING)
• The Ohio State University - The James /ID# 260475 — Columbus, Ohio, United States (RECRUITING)
• University of Texas MD Anderson Cancer Center /ID# 254308 — Houston, Texas, United States (RECRUITING)
• NEXT Oncology /ID# 257395 — San Antonio, Texas, United States (RECRUITING)
• South Texas Accelerated Research Therapeutics /ID# 256944 — San Antonio, Texas, United States (RECRUITING)
• Rambam Health Care Campus /ID# 254608 — Haifa, H_efa, Israel (RECRUITING)
• The Chaim Sheba Medical Center /ID# 259408 — Ramat Gan, Tel-Aviv, Israel (RECRUITING)
• Hadassah Medical Center-Hebrew University /ID# 254606 — Jerusalem, Israel (RECRUITING)
• National Cancer Center Hospital East /ID# 261712 — Kashiwa-shi, Chiba, Japan (RECRUITING)
• Shizuoka Cancer Center /ID# 261714 — Sunto-gun, Shizuoka, Japan (RECRUITING)
• National Cancer Center Hospital /ID# 254359 — Chuo-ku, Tokyo, Japan (RECRUITING)
• Wakayama Medical University Hospital /ID# 254361 — Wakayama, Japan (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Solid Tumors, Non-Small Cell Lung Cancer, NSCLC, Renal Cell Carcinoma, RCC, Head and Neck Squamous Cell Carcinoma, HNSCC, ABBV-303