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RO7566802

Phase 1

Locally Advanced Solid Tumors | Small molecule | Oncology |Roche Holding AG|Last Updated: Jul 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

RO7566802 · 1 trial · 3 indications

Phase 1 1
NCT06031441A 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 TumorsLocally Advanced Solid Tumors
ACTIVE NOT_RECRUITING65 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Locally Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose-limiting Toxicity (DLTs)
Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Up to approximately 4 years

Secondary Endpoints

Area Under the Serum Concentration Time Curve (AUC) of RO7566802
Up to approximately 4 years
Maximum Serum Concentration (Cmax) of RO7566802
Up to approximately 4 years
Minimum Serum Concentration (Cmin) of RO7566802
Up to approximately 4 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation CohortEXPERIMENTALParticipants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Dose Expansion CohortEXPERIMENTALParticipants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
RO7566802DRUGRO7566802 solution for infusion will be administered as specified in each treatment arm.
AtezolizumabDRUGAtezolizumab solution for infusion will be administered as specified in each treatment arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

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 malignanc...

Countries:United StatesAustraliaCanadaSingaporeUnited Kingdom
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Recent Changes (Last 90 Days)

HIGHJul 28, 2026NCT06031441Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 28, 2026NCT06031441Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about RO7566802

What is RO7566802 used for?

RO7566802 is an investigational small molecule being developed for the treatment of locally advanced solid tumors, as well as recurrent and metastatic solid tumors. It is currently being evaluated in a Phase 1 clinical trial in oncology.

Who makes RO7566802?

RO7566802 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to evaluate the drug as a single agent and in combination with atezolizumab.

What phase is RO7566802 in?

RO7566802 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is active but not recruiting participants.

What clinical trials is RO7566802 in?

RO7566802 is being studied in a Phase 1 trial with the identifier NCT06031441. This trial evaluates 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.

Is RO7566802 being tested in combination with other drugs?

Yes, RO7566802 is being studied both as a single agent and in combination with atezolizumab in a Phase 1 clinical trial. The trial is designed to evaluate the safety, pharmacokinetics, and activity of these treatment regimens in patients with solid tumors.

Where is the RO7566802 clinical trial being conducted?

The RO7566802 clinical trial, NCT06031441, is being conducted in multiple countries, including the United States, Australia, Canada, Singapore, and the United Kingdom. The trial enrolls adults aged 18 years and older with locally advanced, recurrent, or metastatic solid tumors.