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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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
Uncontrolled hypertension
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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT05129280

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 12 Locations for this study

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Yale University Cancer Center, Smilow Cancer Hospital; Medical Oncology
New Haven Connecticut, 06511, United States
University of Florida
Gainesville Florida, 32607, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø , 2100, Denmark
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid , 28050, Spain
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT05129280

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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