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Trial record 1 of 1 for:    NCT04857138
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A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04857138
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: [Part 1] Dose-Escalation of RO7300490 as a single agent; [Part 2] Dose-Escalation of RO7300490 in combination with atezolizumab and [Part 3] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RO7300490 Drug: Atezolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : August 17, 2026
Estimated Study Completion Date : August 17, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation (RO7300490 Monotherapy)
Participants will receive escalating doses of RO7300490 intravenously (IV) as a single agent for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
 Drug: RO7300490
Participants will receive RO7300490, as described in the Arm Descriptions.
Experimental: Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)
Participants will receive escalating doses of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label) for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
 Drug: RO7300490
Participants will receive RO7300490, as described in the Arm Descriptions.

Drug: Atezolizumab
Participants will receive Atezolizumab, as described in the Arm Descriptions.
Experimental: Part 3: Dose Expansion (Disease-specific Expansion(s))
Participants with selected types of advanced and/or metastatic tumors will receive the maximum tolerated dose (MTD) or recommended dose for expansion (RDE) (determined from Parts 1 and 2) of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label). Treatment will be administered for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
 Drug: RO7300490
Participants will receive RO7300490, as described in the Arm Descriptions.

Drug: Atezolizumab
Participants will receive Atezolizumab, as described in the Arm Descriptions.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2) [ Time Frame: Up to 36 months ]
  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2) [ Time Frame: Up to 36 months ]
  3. Objective Response Rate (ORR) (Part 3) [ Time Frame: Up to 48 months ]

Secondary Outcome Measures :
  1. Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  2. Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  3. Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  4. Clearance (CL) of RO7300490 (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  5. Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  6. Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  7. Objective Response Rate (ORR) (Parts 1 and 2) [ Time Frame: Up to 48 months ]
  8. Disease Control Rate (DCR) (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  9. Duration of Response (DOR) (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  10. Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3) [ Time Frame: Up to 48 months ]
  11. Percentage of Participants With Adverse Events (AEs) (Part 3) [ Time Frame: Up to 48 months ]

Eligibility Criteria
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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 of >= 12 weeks.
  • Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy.
  • Radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Agreement to provide protocol-specific biopsy material.
  • Adverse Events (AEs) from prior anti-cancer therapy resolved to Grade =<1.
  • Adequate performance status and cardiovascular, hematological, liver, renal and coagulation function.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

  • Known central nervous system (CNS) primary tumors or metastases, including leptomeningeal metastases, unless protocol-specific conditions are met.
  • Active second invasive malignancy within two years prior to screening.
  • Significant cardiovascular/cerebrovascular disease within 6 months prior to study treatment start.
  • Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Active or history of autoimmune disease.
  • Known hypersensitivity to any of the components of RO7300490 formulation or to components of atezolizumab formulation.
  • Pregnancy, lactation or breastfeeding.
  • Dementia or altered mental status that would prohibit informed consent.
  • Major surgery or significant traumatic injury within 28 days prior to the first study drug administration (excluding biopsies) or anticipation of the need for major surgery during study treatment.
  • Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy, immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives of the drug (whichever is shorter) before the first study drug administration.
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): NCT04857138


Contacts
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Contact: Reference Study ID Number: WP42627 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Denmark
Rigshospitalet; Fase 1 Enhed - Onkologi Recruiting
København Ø, Denmark, 2100
France
Gustave Roussy Recruiting
Villejuif, France, 94805
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Spain
Clinica Universitaria de Navarra; Servicio de Oncologia Recruiting
Pamplona, Navarra, Spain, 31008
Vall d?Hebron Institute of Oncology (VHIO), Barcelona Recruiting
Barcelona, Spain, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología Active, not recruiting
Madrid, Spain, 28027
START Madrid-FJD, Hospital Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
United Kingdom
Western General Hospital; Edinburgh Cancer Center Recruiting
Edinburgh, United Kingdom, EH4 2XU
Guys and St Thomas Hospital; OHCT Clinical Trials Recruiting
London, United Kingdom, SE1 9RT
Christie Hospital NHS Trust; Experimental Cancer Medicine Team Recruiting
Manchester, United Kingdom, M20 4BX
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: NCT04857138    
Other Study ID Numbers: WP42627
2020-004489-21 ( EudraCT Number )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Atezolizumab
Immune Checkpoint Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents