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Completed Phase 1 Interventional

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

ClinicalTrials.gov ID: NCT05619744

Public ClinicalTrials.gov record NCT05619744. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 3, 2026, 8:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7616789 in Participants With Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study.

Study identification

NCT ID
NCT05619744
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
41 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 23, 2023 (Actual)
Primary completion
Mar 4, 2025 (Actual)
Completion
Mar 4, 2025 (Actual)
Last update posted
Mar 10, 2025

2023 – 2025

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Georgetown Uni Medical Center Washington D.C. District of Columbia 20007 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Henry Ford Hospital Detroit Michigan 48202-2689 —
Washington University School of Medicine St Louis Missouri 63110 —
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
The Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15232 —
SCRI Oncology Partners Nashville Tennessee 37203 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030-4009 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05619744, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 10, 2025 · Synced Oct 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05619744 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →