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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
Cancer Solid Tumors
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Study Identifier
NCT05129280, BE43244, 2021-000624-35
Condition
Solid Tumors
Official Title
An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
Study 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.
Eligibility Criteria
All
≥18 Years
No
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.
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.
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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Study results
LPS BE43244 Final Results June 2024 English
(PDF, 0.5 MB)
LPS BE43244 Final Results June 2024 Spanish
(PDF, 0.4 MB)
LPS BE43244 Final Results October 2024 French
(PDF, 0.4 MB)
LPS BE43244 Final Results October 2024 Dutch
(PDF, 0.4 MB)
LPS BE43244 Final Results October 2024 English
(PDF, 0.4 MB)
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For the latest version of this information please go to www.forpatients.roche.com