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Small Cell Lung CancerPhase 1NCT05619744

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

A Phase 1 study testing RO7616789 and Tocilizumab in people with Small Cell Lung Cancer and Neuroendocrine Carcinoma, run by Hoffmann-La Roche at 17 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO7616789 and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
17 sitesin 5 countries
Study dates
23 Jan 2023to 4 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

17 sites in 5 countries.

17 sites in 5 countries

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Georgetown Uni Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Japan2 sites

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Cancer Center Hospital

    Tokyo, 104-0045

Other trials in Japan

Denmark1 site

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

Poland1 site

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

Other trials in Poland

About this study

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

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.

Being tested
RO7616789, Tocilizumab
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7616789Drug

    RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.

  • TocilizumabDrug

    Also called Actemra, RoActemra

    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 groups in NCT05619744
Study groupRoleWhat they receive
Part 1: RO7616789 QW: Dose EscalationExperimentalParticipants 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.
Receives: Drug: RO7616789; Drug: Tocilizumab
Part 2: RO7616789 Q3W: Dose EscalationExperimentalParticipants 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.
Receives: Drug: RO7616789; Drug: Tocilizumab
Part 3: Dose ExpansionExperimentalBased on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3.
Receives: Drug: RO7616789; Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1, 2 and 3: Number of Participants with Adverse Events and Serious Adverse Events

    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.

    Measured: Up to approximately 26 months

  2. Part 1 and 2: Number of Participants with Dose Limiting Toxicities (DLTs)

    Measured: Day 1 through Day 21 in cycle 1 (Cycle is 21 days)

  3. Part 3: Objective Response Rate (ORR) as determined by Investigator

    Measured: Up to approximately 26 months

  4. Part 3: Disease Control Rates as Determined by the Investigator

    Measured: Up to approximately 26 months

  5. Part 3: Duration of Response (DOR) as Determined by the Investigator

    Measured: Up to approximately 26 months

  6. Part 3: Progression Free Survival (PFS) as Determined by the Investigator

    Measured: Up to approximately 26 months

  7. Part 3: Overall Survival (OS)

    Measured: Up to approximately 26 months

Secondary outcomes (14)

  1. Part 1, 2 and 3: Serum Concentration of RO7616789

    Measured: Up to approximately 26 months

  2. Part 1, 2 and 3: Maximum Serum Concentration (Cmax) of RO7616789

    Measured: Up to approximately 26 months

  3. Part 1, 2 and 3: Area Under the Concentration-Time Curve (AUC) of RO7616789

    Measured: Up to approximately 26 months

  4. Part 1, 2 and 3: Total Clearance of RO7616789

    Measured: Up to approximately 26 months

  5. Part 1, 2 and 3: Terminal Half-Life of RO7616789

    Measured: Up to approximately 26 months

  6. Part 1, 2 and 3: Volume of Distribution of RO7616789

    Measured: Up to approximately 26 months

  7. Part 1, 2 and 3: Time to Reach Steady State Concentration of RO7616789

    Measured: Up to approximately 26 months

  8. Part 1, 2 and 3: Accumulation Ratio of RO7616789

    Measured: Up to approximately 26 months

  9. Part 1 and 2: ORR as Determined by the Investigators

    Measured: Up to approximately 26 months

  10. Part 1 and 2: Disease Control Rates as Determined by the Investigator

    Measured: Up to approximately 26 months

  11. Part 1 and 2: DOR as Determined by the Investigators

    Measured: Up to approximately 26 months

  12. Part 1 and 2: PFS as Determined by the Investigators

    Measured: Up to approximately 26 months

  13. Part 1 and 2: OS as Determined by the Investigators

    Measured: Up to approximately 26 months

  14. Part 1, 2 and 3: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7616789

    Measured: Up to approximately 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start23 Jan 2023
  3. Primary completion4 Mar 2025
  4. Study completion4 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619744
Sponsor's protocol ID
BP44382
Other IDs
2023-506354-20-00, 2023
Status last verified
Mar 2025
First submitted
9 Nov 2022
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7616789 and Tocilizumab in people with Small Cell Lung Cancer and Neuroendocrine Carcinoma, run by Hoffmann-La Roche at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Spain, Japan, Denmark, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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