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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05129280
Recruitment Status : Active, not recruiting
First Posted : November 22, 2021
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RO7444973 Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 25, 2022
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: From start of treatment up to 21-28 days ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From baseline up to 12 months ]
  2. Disease Control Rate (DCR) [ Time Frame: From baseline up to 12 months ]
  3. 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) ]
  4. 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) ]
  5. Overall Survival (OS) [ Time Frame: From baseline to death from any cause (up to 40 months) ]
  6. 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) ]
  7. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05129280


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Australia, Victoria
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Denmark
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø, Denmark, 2100
Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, Spain, 28050
United Kingdom
Royal Marsden Hospital - Institute of Cancer Research - Sutton
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05129280    
Other Study ID Numbers: BE43244
2021-000624-35 ( EudraCT Number )
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms