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A clinical trial to look at how safe and well RO7616789 works at different doses in people with small cell lung cancer (SCLC) that has spread or any neuroendocrine cancer (NEC), and how the body processes RO7616789
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
- Cancer
- Neuroendocrine Carcinoma
- Lung Cancer
- Small Cell Lung Cancer
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Countries
- Japan
- United States
Trial Identifier:
NCT05619744 2023-506354-20-00 BP44382
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05619744,BP44382,2023-506354-20-00
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is the TRIDENIS clinical trial needed?
The neuroendocrine system is made up of nerves and gland cells that produce hormones. There are neuroendocrine cells in most organs of our body, including the lungs. Small cell lung cancer (SCLC) is a type of neuroendocrine cancer (known as ‘neuroendocrine carcinoma’, or NEC). Standard first treatment of SCLC and other NECs includes chemotherapy and/or medicines that boost the body’s immune system to attack tumours (known as ‘immunotherapy’). However, new treatments are needed that improve health outcomes for people living with SCLCs that have grown or spread to other parts of the body (also called ‘advanced SCLC’) or with other fast-growing (also known as ‘poorly differentiated’) NECs. More than 2 in 3 people with NEC have cancer cells that contain a protein called DLL3, which helps cancer cells to grow. RO7616789 is an investigational type of immunotherapy drug that attaches to DLL3 on cancer cells and, at the same time, attaches to immune cells. RO7616789 works by bringing the two types of cells closer together and activating the immune cells to fight cancer cells.This clinical trial aims to test the safety of RO7616789 and how well it works in people with SCLC and other NECs at different doses and to understand how the body processes RO7616789.
2. How does the TRIDENIS clinical trial work?
This clinical trial is recruiting people with SCLC or another type of NEC. People can take part if they have advanced SCLC or poorly differentiated NEC that has stopped responding to standard treatment (also called ‘relapsed’). People who take part in this clinical trial (participants) will be given the clinical trial treatment RO7616789 for up to 2 years or until their cancer gets worse, they have unacceptable side effects, or they choose to leave the trial. The clinical trial doctor will see them regularly and at least once a week for the first 2 months. These hospital visits will include checks such as scans and heart monitoring to see how the participant responds to the treatment and any side effects they may have. Participants will be required to stay in hospital to be monitored for at least 3 days after the first dose of RO7616789 and maybe again after each higher dose of RO7616789 for the first time. The total time of participation in the clinical trial will depend on how their cancer responds to the clinical trial treatment. This could range from 1 day to about 2 years. Participants can stop trial treatment and leave the clinical trial at any time.
3. What are the main endpoints of the TRIDENIS clinical trial?
The main clinical trial endpoints (the main results measured in the trial to see if the drug has worked) are:
- The number and seriousness of side effects
- What happens to RO7616789 at different doses in the body, and the maximum dose of RO7616789 that can be given before unacceptable side effects occur
- The number of participants whose cancer has stayed the same (disease control rate), has gone away or has reduced in size (objective response rate) and the amount of time this lasts if disease progresses (duration of response)
- How long between the start of the trial treatment and the progression of a participants’ disease (progression-free survival) and how long participants live (overall survival)
The other clinical trial endpoints include how RO7616789 moves around the body and how it affects the body’s immune system.
4. Who can take part in this clinical trial?
People can take part in this trial if they are at least 18 years of age and have been diagnosed with advanced SCLC or another NEC that has relapsed after at least one previous treatment.
People may not be able to take part in this trial if they have had certain treatments and anti-cancer medicines before, including immunotherapies, or had a serious reaction to them. People may also not be able to take part if they have certain other medical conditions such as cancer that has spread to the brain or spinal cord, other cancers, heart disease, uncontrolled type 2 diabetes, or have had a recent epileptic seizure or stroke. People cannot take part if they are pregnant or breastfeeding or are planning to become pregnant during or soon after the trial.
5. What treatment will participants be given in this clinical trial?
Everyone who joins this clinical trial will be given RO7616789 as an infusion (into the vein) either weekly or every 3 weeks. If a participant experiences a potential side effect called ‘cytokine release syndrome’ (CRS), they may receive another drug called tocilizumab.
This is an open-label trial, which means everyone involved, including the participant and the clinical trial doctor, will know the clinical trial treatment the participant has been given.
6. Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe, even life-threatening, and vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments will be performed regularly.
RO7616789
RO7616789 has not yet been tested in humans. For this reason, this drug’s side effects are not known now. Participants will be told about the possible side effects based on laboratory studies or knowledge of similar drugs. Potential participants will be told about the known side effects of tocilizumab, and where relevant, potential side effects based on human and laboratory studies or knowledge of similar drugs. RO7616789 and tocilizumab will be given as an infusion (into the vein). Participants will be told about any known side effects of infusions.
Potential benefits associated with the clinical trial
Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT05619744,BP44382,2023-506354-20-00
Trial Identifier
RO7616789, Tocilizumab
Treatments
Small Cell Lung Cancer, Neuroendocrine Carcinoma
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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 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
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. 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
For the latest version of this information please go to www.forpatients.roche.com