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A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04158583
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : July 12, 2022
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RO7296682 Phase 1

Detailed Description:
A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumors. RO7296682 will be administered by intravenous (IV) infusion every 3 weeks. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, PK (Pharmacokinetics)/PD (Pharmacodynamics) of RO7296682, a T-regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumors.
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Part A
Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682. RO7296682 will be administered by intravenous (IV) infusion in a three-weekly schedule (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.
Drug: RO7296682
RO7296682 will be administered as per the schedules specified in the respective arms.

Experimental: Part B
Dose-Expansion: Will start once MTD/RP2D dose is defined in Part A. Participants will receive a fixed dose of RO7296682 at the dosing regimen established in part A (Q3W schedule).
Drug: RO7296682
RO7296682 will be administered as per the schedules specified in the respective arms.

Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Up to 28 months ]
    Severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0)

  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: 28 Days in Part A ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 28 months ]
  2. Disease Control Rate (DCR) [ Time Frame: Up to 28 months ]
  3. Duration of Response (DOR) [ Time Frame: Up to 28 months ]
  4. Progression-Free Survival (PFS) [ Time Frame: Up to 28 months ]
  5. Area under the curve (AUC) of RO7296682 [ Time Frame: Up to 28 months ]
  6. Minimum Concentration (Cmin) of RO7296682 [ Time Frame: Up to 28 months ]
  7. Maximum Concentration (Cmax) of RO7296682 [ Time Frame: Up to 28 months ]
  8. Clearance (CL) of RO7296682 [ Time Frame: Up to 28 months ]
  9. Volume of distribution at steady-state conditions (Vss) of RO7296682 [ Time Frame: Up to 28 months ]
  10. Half-life (t~1/2) of RO7296682 [ Time Frame: Up to 28 months ]
  11. Time of maximum concentration (Tmax) of RO7296682 [ Time Frame: Up to 28 months ]
  12. Incidence and titer of Anti-Drug Antibodies (ADA) during the study relative to the prevalence of ADA at baseline [ Time Frame: Up to 28 months ]
  13. Treatment-induced changes in Treg levels in blood and/or tumor as compared to baseline [ Time Frame: Up to 28 months ]
  14. Treatment-induced changes in Treg/Teff (T-regulatory cell; T-effector cell) ratio in blood and/or tumor as compared to baseline [ Time Frame: Up to 28 months ]

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

Inclusion Criteria:

  1. Diagnosis of advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC. Participants whose tumors have known sensitizing mutation must have experienced disease progression (during or after treatment) or intolerance to treatment with a respective targeted therapy.
  2. Measurable disease according to RECIST v1.1.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Able to provide the most recent archival tumor tissue samples.
  5. Adequate cardiovascular, haematological, liver and renal function.
  6. Participants on therapeutic anticoagulation must be on a stable anticoagulant regimen.
  7. Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
  8. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

Exclusion Criteria:

  1. Pregnancy, lactation, or breastfeeding.
  2. Known hypersensitivity to any of the components of RO7296682, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
  3. History or clinical evidence of central nervous system (CNS) primary tumors or metastases.
  4. Participants with another invasive malignancy in the last two years.
  5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
  6. Participants with known active or uncontrolled infection.
  7. Positive HIV test at screening.
  8. Positive for Hepatitis B and C.
  9. Vaccination with live vaccines within 28 days prior to C1D1.
  10. Major surgical procedure or significant traumatic injury within 28 days prior to first RO7296682 infusion.
  11. Participants with wound healing complications.
  12. Dementia or altered mental status that would prohibit informed consent.
  13. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS (drug rash with eosinophilia and systemic symptoms).
  14. Active or history of autoimmune disease or immune deficiency.
  15. Prior treatment with CPIs (e.g. anti-CTLA4, anti-PD1, anti-PDL1), immunomodulatory monoclonal antibodies (mAbs) and/or mAb-derived therapies (approved or investigational) is approved.
  16. Prior treatment with a CC chemokine receptor 4 (CCR4)-targeting (e.g. mogamulizumab) or a CD25-targeting agent (e.g. basiliximab) is prohibited.
  17. Treatment with standard radiotherapy, any chemotherapeutic agent, targeted therapy or treatment with any other investigational drug (defined as treatment for which there is currently no regulatory authority-approved indication) within 28 days or 5 half-lives of the drug (whichever is shorter), prior to the first RO7296882 administration on C1D1.
  18. Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy (for which no wash out period is required).

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): NCT04158583

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Australia, Victoria
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, Australia, 3000
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Canada, British Columbia
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K2H 6C2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Rigshospitalet; Onkologisk Klinik
København Ø, Denmark, 2100
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain, 08035
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain, 28040
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04158583    
Other Study ID Numbers: WP41188
2019-002830-35 ( EudraCT Number )
RG6292 ( Other Identifier: Hoffmann-La Roche )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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/members/ourmembers/). 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
Keywords provided by Hoffmann-La Roche:
Additional relevant MeSH terms:
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