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

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


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.

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


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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note