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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT06031441
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Recurrent Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7566802 — DRUG
    RO7566802 solution for infusion will be administered as specified in each treatment arm.
  • Atezolizumab — DRUG
    Atezolizumab solution for infusion will be administered as specified in each treatment arm.

Study Details

This 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.

Key Dates

Start date
Nov 27, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort
    Participants 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.
  • Experimental: Dose Expansion Cohort
    Participants 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.

Primary Outcome Measure

Number of Participants with Dose-limiting Toxicity (DLTs) [ Time Frame: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days) ]

Central Contacts

  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
    888-662-6728 (U.S. Only)
    [email protected]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB)BirminghamAlabama35233-
Yale Cancer CenterNew HavenConnecticut06520-
Icahn School of Medicine at Mount Sinai (ISMMS)New YorkNew York10029-
The Ohio State UniversityColumbusOhio43221-3502-
Magee-Woman's HospitalHarrisburgPennsylvania17109-
SCRI Oncology PartnersNashvilleTennessee37203-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB)· Birmingham, ALYale Cancer Center· New Haven, CTIcahn School of Medicine at Mount Sinai (ISMMS)· New York, NYThe Ohio State University· Columbus, OHMagee-Woman's Hospital· Harrisburg, PASCRI Oncology Partners· Nashville, TN

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