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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT06158958

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested an experimental drug called ABBV-303, alone or with another drug (budigalimab), in adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. The study was terminated early, and results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

27 people

The number who actually took part.

Started

Feb 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

Contacts and locations

Locations

  • Carolina BioOncology Institute /ID# 254305

    Huntersville, North Carolina, 28078, United States

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792

    Irvine, California, 92618, United States

  • City of Hope /ID# 254303

    Duarte, California, 91010, United States

  • Hadassah Medical Center-Hebrew University /ID# 254606

    Jerusalem, 91120, Israel

  • NEXT Oncology /ID# 257395

    San Antonio, Texas, 78229, United States

  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943

    New York, New York, 10016, United States

  • National Cancer Center Hospital /ID# 254359

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 261712

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Rambam Health Care Campus /ID# 254608

    Haifa, 3109601, Israel

  • START Midwest /ID# 256945

    Grand Rapids, Michigan, 49546-7062, United States

  • Shizuoka Cancer Center /ID# 261714

    Sunto-gun, Shizuoka, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics /ID# 256944

    San Antonio, Texas, 78229, United States

  • The Chaim Sheba Medical Center /ID# 259408

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Ohio State University - The James /ID# 260475

    Columbus, Ohio, 43210-1240, United States

  • University of Southern California /ID# 254356

    Los Angeles, California, 90033, United States

  • University of Texas MD Anderson Cancer Center /ID# 254308

    Houston, Texas, 77030, United States

  • Wakayama Medical University Hospital /ID# 254361

    Wakayama, Wakayama, 641-8510, Japan

  • Washington University-School of Medicine /ID# 262943

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.