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

Genentech

Status and phase

Withdrawn

Phase 1

Conditions

Recurrent Cancer

Solid Tumor, Adult

Refractory Cancer

Treatments

Drug: RO7617991

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06372574

GO44669

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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