Clinical trial NCT06372574: A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Refractory Cancer
Recurrent Cancer
Solid Tumor, Adult
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and Severity of Adverse Events
timeFrame: From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
measure: Number of Participants with Abnormal Values in Targeted Vital Signs
timeFrame: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
measure: Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters
timeFrame: From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Secondary outcomes:
measure: Serum Concentration of RO7617991 at Specific Timepoints
timeFrame: From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)
measure: Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1
timeFrame: From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)
measure: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
timeFrame: From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)
measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
timeFrame: From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
measure: Overall Survival (OS)
timeFrame: From enrollment to death from any cause (up to approximately 3 years)
measure: Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study
timeFrame: Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: