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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Budigalimab; Drug: ABBV-303

Study type: Interventional

Funder types: Industry

Identifiers

NCT06158958

M24-122

2023-504714-30 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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192 participants in 7 patient groups

ABBV-303 Dose Escalation: Part 1A Monotherapy

Experimental group

Description:

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:

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 2A Monotherapy

Experimental group

Description:

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:

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 3A Monotherapy

Experimental group

Description:

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

Treatment:

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 4A Monotherapy

Experimental group

Description:

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

Treatment:

Drug: ABBV-303

ABBV-303 Dose Expansion: Part 5A Monotherapy

Experimental group

Description:

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:

Drug: ABBV-303

ABBV-303 Dose Escalation: Part 1B Combination

Experimental group

Description:

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:

Drug: ABBV-303

Drug: Budigalimab

ABBV-303 Dose Expansion: Part 2B Combination

Experimental group

Description:

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:

Drug: ABBV-303

Drug: Budigalimab