A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Recurrent Solid Tumors | Locally Advanced Solid Tumors | Metastatic Solid TumorsThis is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life expectancy \>=3 months, in the investigator's judgment
* Adequate hematologic and end-organ function
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
* Measurable disease per RECIST v1.1
* Tumor specimen availability, for certain cohorts
Exclusion Criteria:
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
* Active hepatitis B or C
* Active tuberculosis
* Positive test for HIV infection
* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation
* Uncontrolled tumor-related pain
* Significant cardiovascular disease
Other protocol-defined inclusion/exclusion criteria may apply.
Lieu de l'étude
British Columbia Cancer Agency - 600 10th Ave W
British Columbia Cancer Agency - 600 10th Ave WVancouver, British Columbia
Canada
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Princess Margaret Cancer Centre
Princess Margaret Cancer CentreToronto, Ontario
Canada
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- Étude parrainée par
- Genentech, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06031441