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.
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
Interventions
Drug | Synonyms | Arms |
---|
RO7300490 | | Part 1: Dose Escalation (RO7300490 Monotherapy) |
Atezolizumab | | Part 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
Name | Type | Description | Interventions |
---|
Part 1: Dose Escalation (RO7300490 Monotherapy) | Experimental | 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. | |
Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy) | Experimental | 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. | |
Part 3: Dose Expansion (Disease-specific Expansion(s)) | Experimental | 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. | |
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