Clinical trial · Interventional

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

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

NCT06372574CI-TRIAL-00080393withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): GO44669 study has been withdrawn due to an internal Sponsor decision. The decision was not due to any safety or efficacy concerns with the study drug.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent Cancer	Malignant Neoplasm	CURATED_BROADER	0.78
Refractory Cancer	Malignant Neoplasm	CURATED_BROADER	0.78
Solid Tumor, Adult	Adult Solid Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
RO7617991	Drug	—	UNRESOLVED
Tocilizumab	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
RO7617991 Dose Escalation and Expansion
interventionNames
1. Drug: RO7617991
2. Drug: Tocilizumab

Primary outcomes (3)

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)
description
The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.