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

Roche

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: RO7300490; Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857138

2020-004489-21 (EudraCT Number)

WP42627

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Part 1: Dose Escalation (RO7300490 Monotherapy)

Experimental group

Description:

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.

Treatment:

Drug: RO7300490

Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)

Experimental group

Description:

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.

Treatment:

Drug: Atezolizumab

Drug: RO7300490

Part 3: Dose Expansion (Disease-specific Expansion(s))

Experimental group

Description:

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.

Treatment:

Drug: Atezolizumab

Drug: RO7300490