Safety and Efficacy Evaluation of RO7759065 with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
- Trial ID
- 2024-513391-17-00
- Protocol
- GO45296
- Sponsor
- Genentech Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **safety** and **effectiveness** of RO7759065 in combination with **Atezolizumab** in participants with **locally advanced or metastatic solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of this combination therapy in a population with advanced cancer, where treatment options may be limited. The study does not specify any secondary objectives.
Participants
The clinical trial involves a total of **84 participants** diagnosed with **locally advanced or metastatic solid tumors**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process aimed to ensure a representative sample of individuals affected by the specified medical condition, without further details on the selection methodology.
Plans and Procedures
The clinical trial is designed to evaluate the **safety** and effectiveness of RO7759065 in combination with **atezolizumab** in participants with **locally advanced or metastatic solid tumors**. This study is a Phase 1 trial, characterized by a randomized, double-blind, and controlled design. The estimated recruitment start date is July 31, 2025, with an anticipated end date of February 28, 2027, indicating an overall trial duration of approximately 19 months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and to collect data on safety and efficacy. These visits will be scheduled at regular intervals throughout the study period. The end-of-study visit will occur after the final treatment cycle, where comprehensive assessments will be conducted to evaluate the overall outcomes of the trial.
The expected length of participant involvement will vary depending on individual response to treatment and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. Participants will be closely monitored to ensure their safety and well-being throughout the trial.
Treatment
The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.
Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.
Furthermore, the documentation lacks information on the **compliance monitoring** of participants, including any dosing schedules or additional relevant information about drug administration. The absence of these details limits the ability to provide a comprehensive description of the treatments involved in the clinical trial.
Efficacy
No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information on parameters or endpoints, methods, schedules, or tools for efficacy assessment is not included. The trial is categorized as Phase 1, with an estimated recruitment start date of July 31, 2025, and an estimated end date of February 28, 2027. Further details on efficacy assessment would typically involve the use of validated scales, laboratory tests, or patient-reported outcomes, but such specifics are not available in the current dataset.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
France | Not Recruiting | 31 Jul 2025 | 12 |
Italy | Not Recruiting | 31 Jul 2025 | 10 |
Spain | Not Recruiting | 31 Jul 2025 | 10 |



