A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372574
• Other study ID #: GO44669
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: May 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: GO44669 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Body weight =40 kilograms
• Life expectancy of at least 12 weeks
• Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression
• Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
• Measurable disease, according to RECIST v1.1
• Adequate hematologic and end-organ function
• Resolution to Grade =2 of all acute, clinically significant treatment-related toxicity from prior therapy
• An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required

Exclusion Criteria:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
• Clinically significant cardiopulmonary dysfunction
• Clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Active hepatitis B or C infection
• Positive test for human immunodeficiency virus (HIV)
• History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
• Active or history of autoimmune disease or immune deficiency
• Treatment with systemic immunosuppressive medications
• Prior allogeneic stem cell or solid organ transplantation

Related Conditions & MeSH terms

• Recurrence
• Recurrent Cancer
• Refractory Cancer
• Solid Tumor, Adult

Intervention

Drug:
• RO7617991
RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
• Tocilizumab
Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre-Box Hill	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Adverse Events		From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Primary	Number of Participants with Abnormal Values in Targeted Vital Signs	The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.	From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Primary	Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters		From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Secondary	Serum Concentration of RO7617991 at Specific Timepoints		From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)
Secondary	Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1	RECIST v1.1 = Response Evaluation Criteria in Solid Tumors, Version 1.1	From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)
Secondary	Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1		From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)
Secondary	Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1		From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
Secondary	Overall Survival (OS)		From enrollment to death from any cause (up to approximately 3 years)
Secondary	Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study		Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)