A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors

NCT ID: NCT06372574

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-02-01

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.

Conditions

Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RO7617991 Dose Escalation and Expansion

Group Type: EXPERIMENTAL

RO7617991

Intervention Type: DRUG

RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Tocilizumab

Intervention Type: DRUG

Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.

Interventions

RO7617991

RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Intervention Type: DRUG

Tocilizumab

Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.

Intervention Type: DRUG

Other Intervention Names

Actemra®; RoActemra®; RO4877533

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Body weight ≥40 kilograms
• Life expectancy of at least 12 weeks
• Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
• Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
• Measurable disease, according to RECIST v1.1
• Adequate hematologic and end-organ function
• Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
• An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required

Exclusion Criteria

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
• Clinically significant cardiopulmonary dysfunction
• Clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Active hepatitis B or C infection
• Positive test for human immunodeficiency virus (HIV)
• History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
• Active or history of autoimmune disease or immune deficiency
• Treatment with systemic immunosuppressive medications
• Prior allogeneic stem cell or solid organ transplantation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

GO44669

Identifier Type: -

Identifier Source: org_study_id