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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2026
  • participants needed
    260
  • sponsor
    Hoffmann-La Roche
Updated on 21 October 2022

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.

Details
Condition Solid Tumors
Treatment Tocilizumab, RO7444973
Clinical Study IdentifierNCT05129280
SponsorHoffmann-La Roche
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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-A02:01 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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