Melanoma Clinical Trial
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A*02:01 allele.
Key Inclusion Criteria:
Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
Confirmed HLA-A*02:01 haplotype
Confirmed MAGE-A4 expression
Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Life expectancy of >/=12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Absence of rapid disease progression, threat to vital organs or non-irradiated lesions >2 cm in diameter at critical sites
No significant ongoing toxicity from prior anticancer treatment
Adequate hematological function
Adequate liver function
Adequate renal function
If applicable, willingness to use contraceptive measures.
Key Exclusion Criteria:
History or clinical evidence of CNS primary tumors or metastases
Another invasive malignancy in the last 2 years
Significant cardiovascular disease
Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
Current or past history of CNS disease
Dementia or altered mental status that would prohibit informed consent
Active auto-immune disease or flare within 6 months prior to start of study treatment
Expected need for regular immunosuppressive therapy or with systemic corticosteroids
Insufficient washout from prior anti-cancer therapy
Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.
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There are 12 Locations for this study
New Haven Connecticut, 06511, United States
Gainesville Florida, 32607, United States
Boston Massachusetts, 02215, United States
Melbourne Victoria, 3000, Australia
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
København Ø , 2100, Denmark
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Madrid , 28050, Spain
Sutton , SM2 5, United Kingdom
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