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CompletedPhase 1NCT05619744
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRO7616789 and Tocilizumab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: RO7616789; Drug: Tocilizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Life expectancy at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function
  • Negative serum pregnancy test.
  • Adequate contraception and no or interruption of breastfeeding
  • Histologically confirmed extensive SCLC or poorly differentiated NEC of any other origin, relapsed after at least 1 systemic therapy
  • Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
  • Confirmed availability of representative archival tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides
Reasons someone may not be able to joinExclusion criteria
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 40 days after the final dose of study treatment
  • Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1c ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L)
  • QT interval corrected using Fridericia's formula (QTcF) \> 470 ms. Abnormal electrocardiograms (ECGs) (triplicate) should be performed \> 30 minutes apart
  • Current treatment with medications that are well known to prolong the QT interval
  • Prior treatment with anti-cluster of differentiation (CD)137 agents, anti-CD3 agents and/or delta-like ligand 3 (DLL3) targeted therapies
  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 21 days prior to initiation of study treatment
  • Any history of an immune-related Grade 4 adverse event (AE) attributed to prior anti-programmed death ligand-1 (PD-L1) /PD-1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) therapy (other than asymptomatic elevation of serum amylase or lipase)
  • Any history of an immune-related Grade 3 adverse event attributed to prior anti-PD-L1 /PD-1 or anti-CTLA-4 therapy (other than asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent
  • History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti-tumor treatment, or leptomeningeal disease and current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Spinal cord compression that has not been definitively treated with surgery and/or radiation
  • Active or history of clinically significant autoimmune disease
  • Positive test for human immunodeficiency virus (HIV) infection
  • Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening
  • Prior allogeneic hematopoietic stem cell transplantation or prior solid organ transplantation
  • Administration of a live, attenuated vaccine within 4 weeks before first RO7616789 infusion
  • Known allergy or hypersensitivity to any component of the RO7616789 formulation

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Georgetown Uni Medical CenterWashington D.C., District of Columbia
  • Massachusetts General HospitalBoston, Massachusetts
  • Henry Ford HospitalDetroit, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • SCRI Oncology PartnersNashville, Tennessee
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • RigshospitaletKøbenhavn Ø
  • National Cancer Center Hospital EastChiba

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2025. Always confirm current availability with the study team.

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