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

Solid Tumors Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04857138
• Other study ID #: WP42627
• Secondary ID: 2020-004489-21
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2021
• Est. completion date: January 18, 2024

Study information

• Verified date: February 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• RO7300490
Participants will receive RO7300490, as described in the Arm Descriptions.
• Atezolizumab
Participants will receive Atezolizumab, as described in the Arm Descriptions.

Locations

Country	Name	City	State
Denmark	Rigshospitalet; Fase 1 Enhed - Onkologi	København Ø
France	Gustave Roussy	Villejuif
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Clinica Universidad de Navarra Madrid; Servicio de Oncología	Madrid
Spain	START Madrid-FJD, Hospital Fundacion Jimenez Diaz	Madrid
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
United Kingdom	Western General Hospital; Edinburgh Cancer Center	Edinburgh
United Kingdom	Guys and St Thomas Hospital; OHCT Clinical Trials	London
United Kingdom	Christie Hospital NHS Trust; Experimental Cancer Medicine Team	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Denmark,  France,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)		Up to 36 months
Primary	Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)		Up to 36 months
Primary	Objective Response Rate (ORR) (Part 3)		Up to 48 months
Secondary	Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)		Up to 48 months
Secondary	Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)		Up to 48 months
Secondary	Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)		Up to 48 months
Secondary	Clearance (CL) of RO7300490 (Parts 1, 2 and 3)		Up to 48 months
Secondary	Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)		Up to 48 months
Secondary	Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3)		Up to 48 months
Secondary	Objective Response Rate (ORR) (Parts 1 and 2)		Up to 48 months
Secondary	Disease Control Rate (DCR) (Parts 1, 2 and 3)		Up to 48 months
Secondary	Duration of Response (DOR) (Parts 1, 2 and 3)		Up to 48 months
Secondary	Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3)		Up to 48 months
Secondary	Percentage of Participants With Adverse Events (AEs) (Part 3)		Up to 48 months