Clinical Trials /

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

NCT04857138

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: WP42627
  • SECONDARY ID: 2020-004489-21
  • NCT ID: NCT04857138

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
RO7300490Part 1: Dose Escalation (RO7300490 Monotherapy)
AtezolizumabPart 2: Dose Escalation (RO7300490/atezolizumab combination therapy)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose Escalation (RO7300490 Monotherapy)ExperimentalParticipants 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.
  • RO7300490
Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)ExperimentalParticipants 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.
  • RO7300490
  • Atezolizumab
Part 3: Dose Expansion (Disease-specific Expansion(s))ExperimentalParticipants 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.
  • RO7300490
  • Atezolizumab

Eligibility 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.

          -  Active second malignancy requiring anticancer treatment and/or palliative supportive
             care.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)
Time Frame:Up to 36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Clearance (CL) of RO7300490 (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) (Parts 1 and 2)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Disease Control Rate (DCR) (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Duration of Response (DOR) (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3)
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events (AEs) (Part 3)
Time Frame:Up to 48 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

August 24, 2021