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 | Completed Phase 1

• 2 other identifiers: WP426272020-004489-21
• Study Type: interventional
• Target: 80
• Locations: 5 countries
• Sites: 11

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)

  Up to 36 months

• Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)

  Up to 36 months

• Objective Response Rate (ORR) (Part 3)

  Up to 48 months

Secondary Outcomes (11)

• Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)

  Up to 48 months

• Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)

  Up to 48 months

• Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)

  Up to 48 months

• Clearance (CL) of RO7300490 (Parts 1, 2 and 3)

  Up to 48 months

• Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)

  Up to 48 months

Study Arms (3)

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.

Drug: RO7300490

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.

Drug: RO7300490; Drug: Atezolizumab

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.

Drug: RO7300490; Drug: Atezolizumab

Interventions

RO7300490 DRUG

Participants will receive RO7300490, as described in the Arm Descriptions.

Part 1: Dose Escalation (RO7300490 Monotherapy); Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy); Part 3: Dose Expansion (Disease-specific Expansion(s))

Atezolizumab DRUG

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

Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy); Part 3: Dose Expansion (Disease-specific Expansion(s))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Rigshospitalet; Fase 1 Enhed - Onkologi

København Ø, 2100, Denmark

Location

Gustave Roussy

Villejuif, 94805, France

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra Madrid; Servicio de Oncología

Madrid, 28027, Spain

Location

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Western General Hospital; Edinburgh Cancer Center

Edinburgh, EH4 2XU, United Kingdom

Location

Guys and St Thomas Hospital; OHCT Clinical Trials

London, SE1 9RT, United Kingdom

Location

Christie Hospital NHS Trust; Experimental Cancer Medicine Team

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

atezolizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 23, 2021
• Study Start: May 18, 2021
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

GB (3); FR (1); DK (1); KR (2); ES (4)