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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158958
• Other study ID #: M24-122
• Secondary ID: 2023-504714-30
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2024
• Est. completion date: January 19, 2028

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: January 19, 2028
• Est. primary completion date: January 19, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• ABBV-303
Intravenous (IV) Infusion
• Budigalimab
IV Infusion

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus /ID# 254608	Haifa	H_efa
Israel	Hadassah Medical Center /ID# 254606	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 259408	Ramat Gan	Tel-Aviv
United States	START Midwest /ID# 256945	Grand Rapids	Michigan
United States	University of Texas MD Anderson Cancer Center /ID# 254308	Houston	Texas
United States	Carolina BioOncology Institute /ID# 254305	Huntersville	North Carolina
United States	NEXT Oncology /ID# 257395	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics /ID# 256944	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 3 Years
Secondary	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.	Up to 3 Years
Secondary	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.	Up to 3 Years
Secondary	Overall survival (OS)	OS is defined as time from first study treatment to death due to any cause.	Up to 3 Years
Secondary	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.	Up to 3 Years

External Links

•   Related Info