Under construction – not a live service
Sign in
TerminatedPhase 1

A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors

Key facts

Who runs it
AbbVie
Where
Columbus, Duarte, Grand Rapids, Houston, Huntersville, Irvine, Los Angeles, New York, San Antonio, and St Louis, United StatesSee the 11 sitesAlso in 2 other countries, 7 sites
Status
Terminated
Phase
Phase 1
People taking part
27 people enrolled
Started
6 Feb 2024
Ended
22 Oct 2025
Type of study
Interventional, 7 groups
Treatments tested
  • ABBV-303
  • Budigalimab
Record updated
27 October 2025
Why it stopped
Strategic considerations

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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 in United States

Also in 2 other countries, 7 sites

  • The Ohio State University - The James /ID# 260475Columbus, United StatesNo longer taking part
  • City of Hope /ID# 254303Duarte, United StatesNo longer taking part
  • START Midwest /ID# 256945Grand Rapids, United StatesNo longer taking part
  • University of Texas MD Anderson Cancer Center /ID# 254308Houston, United StatesNo longer taking part
  • Carolina BioOncology Institute /ID# 254305Huntersville, United StatesNo longer taking part
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792Irvine, United StatesNo longer taking part
  • University of Southern California /ID# 254356Los Angeles, United StatesNo longer taking part
  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943New York, United StatesNo longer taking part
  • NEXT Oncology /ID# 257395San Antonio, United StatesNo longer taking part
  • South Texas Accelerated Research Therapeutics /ID# 256944San Antonio, United StatesNo longer taking part
  • Washington University-School of Medicine /ID# 262943St Louis, United StatesNo longer taking part

About the trial

What the trial wants to find out

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181).

Read full original descriptionShow less

ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide.

In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

The 7 groups in the trial

  • ABBV-303 Dose Escalation: Part 1A MonotherapyTreatment being tested

    Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.

    Treatment: ABBV-303

  • ABBV-303 Dose Expansion: Part 2A MonotherapyTreatment being tested

    Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.

    Treatment: ABBV-303

  • ABBV-303 Dose Expansion: Part 3A MonotherapyTreatment being tested

    Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

    Treatment: ABBV-303

  • ABBV-303 Dose Expansion: Part 4A MonotherapyTreatment being tested

    Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

    Treatment: ABBV-303

  • ABBV-303 Dose Expansion: Part 5A MonotherapyTreatment being tested

    Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.

    Treatment: ABBV-303

  • ABBV-303 Dose Escalation: Part 1B CombinationTreatment being tested

    Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.

    Treatment: ABBV-303 and Budigalimab

  • ABBV-303 Dose Expansion: Part 2B CombinationTreatment being tested

    Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.

    Treatment: ABBV-303 and Budigalimab

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
27 October 2025