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Renal Cell CarcinomaPhase 1NCT05769959

Study of RO7515629 in Participants With HLA-G Positive Solid Tumors

A Phase 1 study testing RO7515629 and tocilizumab in people with Renal Cell Carcinoma and Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RO7515629 and tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
15 Jun 2023to 19 Mar 2024
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

  • Unresectable and/or metastatic HLA-G-positive solid tumors, for which standard therapy does not exist, or has proven to be ineffective or intolerable
  • Confirmed HLA-G tumor expression.
  • Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematological, liver, renal and pulmonary function
  • Willingness to abide by protocol defined contraceptive requirements for the duration of the study.

Who cannot join

  • History or clinical evidence of Central Nervous System (CNS) metastases unless protocol specified criteria are met
  • Leptomeningeal metastases
  • Rapid disease progression including lesions that are a threat to vital organs or non-irradiated lesions 2cm or larger at critical sites where tumor swelling may pose a risk to critical anatomical structures
  • Participants with another invasive malignancy in the last 2 years unless protocol specified criteria are met
  • Uncontrolled hypertension
  • Active interstitial lung disease (ILD), pneumonitis or a history of ILD/pneumonitis requiring treatment with steroids, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan
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  • Participants with central cavitation or tumor(s) shown to be invading or abutting major blood vessels by imaging or the Investigator determines the tumor(s) is likely to invade major blood vessels and cause fatal bleeding
  • Participants with pulmonary military metastatic pattern or pulmonary lymphangitic carcinomatosis
  • History of pulmonary embolism within 3 months prior to study entry
  • Significant cardiovascular disease
  • Presence of active or uncontrolled infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to initiation of study treatment.
  • Known hepatitis B or C (actively replicating) based on protocol specified criteria
  • Known Human Immunodeficiency Virus (HIV) positivity
  • Presence of an indwelling line or drain
  • Active auto-immune disease that has required systemic therapy within the past 2 years unless protocol specified exceptions are met
  • Major surgery within 28 days prior to first study treatment
  • Last treatment with anti-cancer therapy or any investigational drug 28 days or less prior to the first study treatment
  • Last dose of immunostimulating or immunosuppressive therapy 28 days or less prior to the first study treatment
  • Regular dose of corticosteroids that exceeds prednisone 10 mg/day or equivalent within 28 days prior to first study treatment
  • Prior treatment with T cell engaging or adoptive cell therapy
  • Administration of a live, attenuated vaccine 28 days or less prior to first study treatment
  • Contraindication or known hypersensitivity to any of the components of RO7515629 or tocilizumab or dexamethasone

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7515629 in Participants With Unresectable and/or Metastatic HLA-G Positive Solid Tumors

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immune response and preliminary anti-tumor activity of RO7515629 alone in participants with advanced or metastatic solid tumors expressing human leukocyte antigen G (HLA-G).

Being tested
RO7515629, tocilizumab
Keywords
HLA-G, Human leukocyte antigen G, Renal cell carcinoma, Non-small cell lung cancer, Pancreatic adenocarcinoma, Colorectal cancer, Epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, RO7515629, Tocilizumab
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

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

  • RO7515629Drug

    RO7515629 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

  • tocilizumabDrug

    Also called Actemra, RoActemra

    Tocilizumab will be used as rescue medication only. Tocilizumab will be administered as required for the management of cytokine release syndrome (CRS).

Study groups in NCT05769959
Study groupRoleWhat they receive
Part I Single Participant Cohort RO7515629 Dose EscalationExperimentalParticipants will receive a fixed dose of RO7515629 intravenously as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Receives: Drug: RO7515629; Drug: tocilizumab
Part II Multiple Participant Cohort RO7515629 Dose EscalationExperimentalParticipants will receive RO7515629 intravenously, as a single agent on cycle 0 day -7 and 7 days later on cycle 1 day 1 followed by every three-week dosing frequency. In case of toxicity, step up dosing (single or double) may be implemented. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Receives: Drug: RO7515629; Drug: tocilizumab
Part III Multiple Participant Cohort RO7515629 Dose ExpansionExperimentalParticipants with selected solid tumors will receive a selected dose of RO7515629 intravenously as a single agent based on the recommended dose sequence for expansion (RDE) and dosing regimen selected from Part I and Part II. Treatment may continue for up to 12 months maximum or until progression, loss of clinical benefit, intolerable toxicity, withdrawal from study treatment or death.
Receives: Drug: RO7515629; Drug: tocilizumab

What is being measured

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

  1. Part 1, 2, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to 15 months

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

    Measured: From start of study treatment (cycle 0 day -7 or cycle 0 day -14) until two weeks after second or third RO7515629 infusion (cycle 1 day 1) for a total DLT window of up to 28 days.

Secondary outcomes (12)

  1. Part 1, 2, 3: Pharmacokinetic Analysis: Maximum Serum Concentration (Cmax) of RO7515629

    Measured: Up to 13 months

  2. Part 1, 2, 3: Pharmacokinetic Analysis: Time of Maximum Serum Concentration (Tmax) of RO7515629

    Measured: Up to 13 months

  3. Part 1, 2, 3: Pharmacokinetic Analysis: Minimum Serum Concentration (Cmin) of RO7515629

    Measured: Up to 13 months

  4. Parts 1, 2, 3: Pharmacokinetic Analysis: Clearance (CL) of RO7515629

    Measured: Up to 13 months

  5. Part 1, 2, 3: Pharmacokinetic Analysis: Volume of Distribution at Steady State (Vss) of RO7515629

    Measured: Up to 13 months

  6. Part 1, 2, 3: Pharmacokinetic Analysis: Area Under The Curve (AUC) of RO7515629

    Measured: Up to 13 months

  7. Part 1, 2, 3: Number of Participants With RO7515629 Anti-drug Antibodies (ADAs)

    Measured: Up to 13 months

  8. Part 1, 2, 3: Objective Response Rate (ORR)

    Measured: Up to approximately 18 months

  9. Part 1, 2, 3: Disease Control Rate (DCR)

    Measured: Up to approximately 18 months

  10. Part 1, 2, 3: Duration of Response (DoR)

    Measured: Up to approximately 18 months

  11. Part 1, 2, 3: Progression Free Survival (PFS)

    Measured: Up to approximately 18 months

  12. Part 1, 2, 3: Overall survival (OS)

    Defined as the time from first dose of study treatment to time of death.

    Measured: Up to approximately 18 months

Timeline

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

  1. First posted15 Mar 2023
  2. Study start15 Jun 2023
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Why it stopped: Sponsor decision (not related to safety, efficacy or quality).

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769959
Sponsor's protocol ID
BP44068
Status last verified
Jul 2024
First submitted
3 Mar 2023
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Epp A, Serrano-Serrano ML, Heil F, Majety M, Silva A, Cheung J, Colpan M, Nair N. Multimodal characterization of HLA-G expression across solid tumors reveals transcript-protein discordance and implications for immunotherapy targeting. Front Immunol. 2026 Sep 24;17:1876556. doi: 10.3389/fimmu.2026.1876556. eCollection 2026.

    PubMed 42851436

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7515629 and tocilizumab in people with Renal Cell Carcinoma and Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 2 sites in United States.

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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 was stopped early (reason given: Sponsor decision (not related to safety, efficacy or quality).). Results are not available in the source record.

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, 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 15 months). The study lists 2 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 NCT05769959, which also lists 1 linked publication.

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 9 Jul 2024.

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