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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

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ClinicalTrials.gov Identifier: NCT05129280
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 19, 2021
First Posted Date  ICMJE November 22, 2021
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE January 25, 2022
Estimated Primary Completion Date October 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2021)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From start of treatment up to 90 days after last RO7444973 dose (up to 15 months) ]
  • Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: From start of treatment up to 21-28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2021)
  • Objective Response Rate (ORR) [ Time Frame: From baseline up to 12 months ]
  • Disease Control Rate (DCR) [ Time Frame: From baseline up to 12 months ]
  • Duration of Response (DoR) [ Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months) ]
  • Progression-free Survival (PFS) [ Time Frame: From baseline to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months) ]
  • Overall Survival (OS) [ Time Frame: From baseline to death from any cause (up to 40 months) ]
  • Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time [ Time Frame: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months) ]
  • Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973 [ Time Frame: From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: RO7444973
    RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.
  • Drug: Tocilizumab
    Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg.
    Other Name: Actemra, RoActemra
Study Arms  ICMJE
  • Experimental: Part I: Single Participant Cohort (SPC) Dose Escalation
    In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.
    Interventions:
    • Drug: RO7444973
    • Drug: Tocilizumab
  • Experimental: Part II: Multiple Participant Cohort (MPC) Dose Escalation
    In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.
    Interventions:
    • Drug: RO7444973
    • Drug: Tocilizumab
  • Experimental: Part III: Recommended Phase 2 Dose (RP2D) Expansion
    Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III.
    Interventions:
    • Drug: RO7444973
    • Drug: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2021)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2026
Estimated Primary Completion Date October 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BE43244 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05129280
Other Study ID Numbers  ICMJE BE43244
2021-000624-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP