A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010

Part of paid clinical trials in Los Angeles, California.

Sponsor
Genentech, Inc.
Study ID
NCT05867121
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • RO7496353 — DRUG
    RO7496353 will be administered as per the schedules specified in the respective arms.
  • Atezolizumab — DRUG
    Atezolizumab will be administered as per the schedules specified in the respective arms.
  • Capecitabine — DRUG
    Capecitabine will be administered as per the schedule specified in the respective arm.
  • S-1 — DRUG
    S-1 will be administered as per the schedule specified in the respective arm.
  • Nivolumab — DRUG
    Nivolumab will be administered as per the schedule specified in the respective arm.
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered as per the schedule specified in the respective arm.
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel will be administered as per the schedule specified in the respective arm.
  • Gemcitabine — DRUG
    Gemcitabine will be administered as per the schedule specified in the respective arm.

Study Details

The purpose of this study is to evaluate the safety and tolerability of RO7496353 in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The substudy will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of RO7496353 in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma (UC). The parent and substudy will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

Key Dates

Start date
Oct 2, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
102 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: NSCLC
    Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression (PD).
  • Experimental: Cohort B: GC
    Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
  • Experimental: Cohort C: PDAC
    Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.
  • Experimental: Substudy: UC
    Participants with UC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to PD.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 33 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
UCLA University of California Los AngelesLos AngelesCalifornia90095-
Yale School of MedicineNew HavenConnecticut06510-3206-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Los Angeles, CA

By condition
Gastric cancerLung cancerPancreatic cancer
By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
UCLA University of California Los Angeles· Los Angeles, CAYale School of Medicine· New Haven, CTThomas Jefferson University· Philadelphia, PA

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