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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hoffmann-La Roche
Study ID
NCT05619744
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • RO7616789 — DRUG
    RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.
  • Tocilizumab — DRUG
    Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
Mar 2025
Primary completion
Mar 4, 2025
Completion
Mar 4, 2025

Study Design

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

Arms

  • Experimental: Part 1: RO7616789 QW: Dose Escalation
    Participants will receive a fixed dose of RO7616789 intravenously once weekly (QW) per dose level on Day 1, 8, and 15 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.
  • Experimental: Part 2: RO7616789 Q3W: Dose Escalation
    Participants will receive a fixed dose of RO7616789, at a dose determined in Part 1, intravenously once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.
  • Experimental: Part 3: Dose Expansion
    Based on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3.

Primary Outcome Measure

Part 1, 2 and 3: Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to approximately 26 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Georgetown Uni Medical CenterWashington D.C.District of Columbia20007-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford HospitalDetroitMichigan48202-2689-
Washington University School of MedicineSt LouisMissouri63110-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Washington D.C., DC

By condition
Neuroendocrine tumorsLung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Georgetown Uni Medical Center· Washington D.C., DCMassachusetts General Hospital· Boston, MAHenry Ford Hospital· Detroit, MIWashington University School of Medicine· St Louis, MOJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NY

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