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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

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ClinicalTrials.gov Identifier: NCT05619744
Recruitment Status : Recruiting
First Posted : November 17, 2022
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Neuroendocrine Carcinoma Drug: RO7616789 Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: RO7616789
RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.

Drug: Tocilizumab
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.
Other Name: Actemra, RoActemra
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.
 Drug: RO7616789
RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.

Drug: Tocilizumab
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.
Other Name: Actemra, RoActemra
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.
 Drug: RO7616789
RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.

Drug: Tocilizumab
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.
Other Name: Actemra, RoActemra


Outcome Measures
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Primary Outcome Measures :
  1. Part 1, 2 and 3: Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to approximately 26 months ]
    Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine release syndrome (CRS), will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.

  2. Part 1 and 2: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 through Day 21 in cycle 1 (Cycle is 21 days) ]
  3. Part 3: Objective Response Rate (ORR) as determined by Investigator [ Time Frame: Up to approximately 26 months ]
  4. Part 3: Disease Control Rates as Determined by the Investigator [ Time Frame: Up to approximately 26 months ]
  5. Part 3: Duration of Response (DOR) as Determined by the Investigator [ Time Frame: Up to approximately 26 months ]
  6. Part 3: Progression Free Survival (PFS) as Determined by the Investigator [ Time Frame: Up to approximately 26 months ]
  7. Part 3: Overall Survival (OS) [ Time Frame: Up to approximately 26 months ]

Secondary Outcome Measures :
  1. Part 1, 2 and 3: Serum Concentration of RO7616789 [ Time Frame: Up to approximately 26 months ]
  2. Part 1, 2 and 3: Maximum Serum Concentration (Cmax) of RO7616789 [ Time Frame: Up to approximately 26 months ]
  3. Part 1, 2 and 3: Area Under the Concentration-Time Curve (AUC) of RO7616789 [ Time Frame: Up to approximately 26 months ]
  4. Part 1, 2 and 3: Total Clearance of RO7616789 [ Time Frame: Up to approximately 26 months ]
  5. Part 1, 2 and 3: Terminal Half-Life of RO7616789 [ Time Frame: Up to approximately 26 months ]
  6. Part 1, 2 and 3: Volume of Distribution of RO7616789 [ Time Frame: Up to approximately 26 months ]
  7. Part 1, 2 and 3: Time to Reach Steady State Concentration of RO7616789 [ Time Frame: Up to approximately 26 months ]
  8. Part 1, 2 and 3: Accumulation Ratio of RO7616789 [ Time Frame: Up to approximately 26 months ]
  9. Part 1 and 2: ORR as Determined by the Investigators [ Time Frame: Up to approximately 26 months ]
  10. Part 1 and 2: Disease Control Rates as Determined by the Investigator [ Time Frame: Up to approximately 26 months ]
  11. Part 1 and 2: DOR as Determined by the Investigators [ Time Frame: Up to approximately 26 months ]
  12. Part 1 and 2: PFS as Determined by the Investigators [ Time Frame: Up to approximately 26 months ]
  13. Part 1 and 2: OS as Determined by the Investigators [ Time Frame: Up to approximately 26 months ]
  14. Part 1, 2 and 3: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7616789 [ Time Frame: Up to approximately 26 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 high grade 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

Exclusion 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 demonstrated by at least two electrocardiogram (ECGs) 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05619744


Contacts
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Contact: Reference Study ID Number: BP44382 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc Recruiting
Nashville, Tennessee, United States, 37203
Japan
National Cancer Center Hospital East; Thoracic Oncology Recruiting
Chiba, Japan, 277-8577
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05619744    
Other Study ID Numbers: BP44382
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue