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Solid TumorsPhase 1NCT06158958

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

A Phase 1 study testing ABBV-303 and Budigalimab in people with Solid Tumors, run by AbbVie at 18 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
ABBV-303 and Budigalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
18 sitesin 3 countries
Study dates
6 Feb 2024to 22 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

United States11 sites

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

    Columbus, Ohio, 43210-1240

  • City of Hope /ID# 254303

    Duarte, California, 91010

  • START Midwest /ID# 256945

    Grand Rapids, Michigan, 49546-7062

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

    Houston, Texas, 77030

  • Carolina BioOncology Institute /ID# 254305

    Huntersville, North Carolina, 28078

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

    Irvine, California, 92618

  • University of Southern California /ID# 254356

    Los Angeles, California, 90033

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

    New York, New York, 10016

  • NEXT Oncology /ID# 257395

    San Antonio, Texas, 78229

  • South Texas Accelerated Research Therapeutics /ID# 256944

    San Antonio, Texas, 78229

  • Washington University-School of Medicine /ID# 262943

    St Louis, Missouri, 63110

Other trials in United States

Japan4 sites

  • National Cancer Center Hospital /ID# 254359

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 261712

    Kashiwa-shi, Chiba, 277-8577

  • Shizuoka Cancer Center /ID# 261714

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital /ID# 254361

    Wakayama, Wakayama, 641-8510

Other trials in Japan

Israel3 sites

  • Rambam Health Care Campus /ID# 254608

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 254606

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 259408

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

About this study

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

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).

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.

Read more

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.

Conditions
Solid Tumors
Being tested
ABBV-303, Budigalimab
Keywords
Solid Tumors, Non-Small Cell Lung Cancer, NSCLC, Renal Cell Carcinoma, RCC, Head and Neck Squamous Cell Carcinoma, HNSCC, ABBV-303, ABBV-181, Budigalimab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-303Drug

    Intravenous (IV) Infusion

  • BudigalimabDrug

    Also called ABBV-181

    IV Infusion

Study groups in NCT06158958
Study groupRoleWhat they receive
ABBV-303 Dose Escalation: Part 1A MonotherapyExperimentalParticipants 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.
Receives: Drug: ABBV-303
ABBV-303 Dose Expansion: Part 2A MonotherapyExperimentalParticipants 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.
Receives: Drug: ABBV-303
ABBV-303 Dose Expansion: Part 3A MonotherapyExperimentalParticipants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Receives: Drug: ABBV-303
ABBV-303 Dose Expansion: Part 4A MonotherapyExperimentalParticipants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Receives: Drug: ABBV-303
ABBV-303 Dose Expansion: Part 5A MonotherapyExperimentalTissue 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.
Receives: Drug: ABBV-303
ABBV-303 Dose Escalation: Part 1B CombinationExperimentalParticipants 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.
Receives: Drug: ABBV-303; Drug: Budigalimab
ABBV-303 Dose Expansion: Part 2B CombinationExperimentalParticipants 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.
Receives: Drug: ABBV-303; Drug: Budigalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AE)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 3 Years

Secondary outcomes (5)

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to RECIST version 1.1.

    Measured: Up to 3 Years

  2. Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1

    DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to 3 Years

  3. Progression-free survival (PFS)

    PFS is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.

    Measured: Up to 3 Years

  4. Overall survival (OS)

    OS is defined as time from first study treatment to death due to any cause.

    Measured: Up to 3 Years

  5. ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)

    ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to iRECIST version 1.1.

    Measured: Up to 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start6 Feb 2024
  3. Primary completion22 Oct 2025
  4. Study completion22 Oct 2025

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158958
Sponsor's protocol ID
M24-122
Other IDs
2023-504714-30, 2023
Status last verified
Oct 2025
First submitted
29 Nov 2023
Last updated
27 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-303 and Budigalimab in people with Solid Tumors, run by AbbVie at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Japan, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AE) (time frame: Up to 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06158958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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