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

NCT06158958 | Terminated Phase 1 FDA Drug

• 2 other identifiers: M24-1222023-504714-30
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 18

Brief 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). 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.

Conditions

Solid Tumors

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

Outcome Measures

Primary Outcomes (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.

  Up to 3 Years

Secondary Outcomes (5)

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

  Up to 3 Years

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

  Up to 3 Years

• Progression-free survival (PFS)

  Up to 3 Years

• Overall survival (OS)

  Up to 3 Years

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

  Up to 3 Years

Study Arms (7)

ABBV-303 Dose Escalation: Part 1A Monotherapy

EXPERIMENTAL

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.

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 2A Monotherapy

EXPERIMENTAL

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.

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 3A Monotherapy

EXPERIMENTAL

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

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 4A Monotherapy

EXPERIMENTAL

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

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 5A Monotherapy

EXPERIMENTAL

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.

Drug: ABBV-303

ABBV-303 Dose Escalation: Part 1B Combination

EXPERIMENTAL

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.

Drug: ABBV-303; Drug: Budigalimab

ABBV-303 Dose Expansion: Part 2B Combination

EXPERIMENTAL

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.

Drug: ABBV-303; Drug: Budigalimab

Interventions

ABBV-303 DRUG

Intravenous (IV) Infusion

ABBV-303 Dose Escalation: Part 1A Monotherapy; ABBV-303 Dose Escalation: Part 1B Combination; ABBV-303 Dose Expansion: Part 2A Monotherapy; ABBV-303 Dose Expansion: Part 2B Combination; ABBV-303 Dose Expansion: Part 3A Monotherapy; ABBV-303 Dose Expansion: Part 4A Monotherapy; ABBV-303 Dose Expansion: Part 5A Monotherapy

Budigalimab DRUG

IV Infusion

Also known as: ABBV-181

ABBV-303 Dose Escalation: Part 1B Combination; ABBV-303 Dose Expansion: Part 2B Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (18)

City of Hope /ID# 254303

Duarte, California, 91010, United States

Location

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

Irvine, California, 92618, United States

Location

University of Southern California /ID# 254356

Los Angeles, California, 90033, United States

Location

START Midwest /ID# 256945

Grand Rapids, Michigan, 49546-7062, United States

Location

Washington University-School of Medicine /ID# 262943

St Louis, Missouri, 63110, United States

Location

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

New York, New York, 10016, United States

Location

Carolina BioOncology Institute /ID# 254305

Huntersville, North Carolina, 28078, United States

Location

The Ohio State University - The James /ID# 260475

Columbus, Ohio, 43210-1240, United States

Location

University of Texas MD Anderson Cancer Center /ID# 254308

Houston, Texas, 77030, United States

Location

NEXT Oncology /ID# 257395

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated Research Therapeutics /ID# 256944

San Antonio, Texas, 78229, United States

Location

The Chaim Sheba Medical Center /ID# 259408

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Campus /ID# 254608

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 254606

Jerusalem, 91120, Israel

Location

National Cancer Center Hospital East /ID# 261712

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Shizuoka Cancer Center /ID# 261714

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital /ID# 254359

Chuo-ku, Tokyo, 104-0045, Japan

Location

Wakayama Medical University Hospital /ID# 254361

Wakayama, Wakayama, 641-8510, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

budigalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 6, 2023
• Study Start: February 6, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); JP (4); US (11)