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NCT05867121 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small Cell Lung Cancer and Gastric Cancer, sponsored by Genentech.
- Active
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT05867121: Active Phase 1 study of Non-Small Cell Lung Cancer and Gastric Cancer, sponsored by Genentech.
NCT05867121 is a Phase 1 study of Non-Small Cell Lung Cancer and Gastric Cancer that is active but no longer recruiting, run by Genentech. The registered enrollment target is 102 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05867121, a Phase 1 study of Non-Small Cell Lung Cancer and Gastric Cancer, is active but no longer recruiting, sponsored by Genentech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Atezolizumab
- DRUG Nivolumab
- DRUG RO7496353
- DRUG S-1
Study Locations (20)
Other
- National Cancer Center Hospital East - Chiba
- Kanagawa Cancer Center - Kanagawa
- Shizuoka Cancer Center - Shizuoka
- National Cancer Center Hospital - Tokyo
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research - Tokyo
- Auckland City Hospital - Auckland
- Seoul National University Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - PPDS - Seoul
- The Catholic University of Korea, Seoul St. Mary's Hospital - Seoul
California
- UCLA University of California Los Angeles - Los Angeles
Connecticut
- Yale School of Medicine - New Haven
Pennsylvania
- Thomas Jefferson University - Philadelphia
New South Wales
- St Vincent'S Hospital - Darlinghurst
South Australia
- Flinders Medical Centre - Bedford Park
Rio Grande do Sul
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) - Porto Alegre
São Paulo
- Hospital de Câncer de Barretos - Barretos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05867121 still lists
NCT05867121 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05867121 names 20 study sites across 11 states, led by Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05867121 about?
NCT05867121 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05867121?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2023-10-02. Estimated completion is 2026-06-30.
What conditions does trial NCT05867121 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT05867121?
The interventions under investigation include: Capecitabine (DRUG), Atezolizumab (DRUG), Nivolumab (DRUG), RO7496353 (DRUG), S-1 (DRUG).
Who is sponsoring clinical trial NCT05867121?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05867121 being conducted?
This trial has 20 study locations across California, Connecticut, Pennsylvania, New South Wales, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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