A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

NCT ID: NCT04303858

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2025-10-03

Brief Summary

This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

Detailed Description

The study consists of three parts: dose-escalation of eciskafusp alfa as a single agent (Part 1), dose-escalation of eciskafusp alfa in combination with atezolizumab (Part 2), and extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab (Part 3).

Conditions

Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eciskafusp Alfa as a Single Agent

Part 1: Dose-escalation of eciskafusp alfa as a single agent. eciskafusp alfa will be either an intravenous administration (IV) or subcutaneous administration (SC) in multiple-ascending doses.

Group Type: EXPERIMENTAL

Eciskafusp Alfa

Intervention Type: DRUG

Participants will be administered eciskafusp alfa in different schedules.

Eciskafusp Alfa in Combination with Atezolizumab

Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab.

Group Type: EXPERIMENTAL

Eciskafusp Alfa

Intervention Type: DRUG

Participants will be administered eciskafusp alfa in different schedules.

Atezolizumab

Intervention Type: DRUG

Participants will be administered 1200 mg of atezolizumab once every 3 weeks.

Eciskafusp Alfa as a Single Agent and/or with Atezolizumab

Part 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab.

Group Type: EXPERIMENTAL

Eciskafusp Alfa

Intervention Type: DRUG

Participants will be administered eciskafusp alfa in different schedules.

Atezolizumab

Intervention Type: DRUG

Participants will be administered 1200 mg of atezolizumab once every 3 weeks.

Interventions

Eciskafusp Alfa

Participants will be administered eciskafusp alfa in different schedules.

Intervention Type: DRUG

Atezolizumab

Participants will be administered 1200 mg of atezolizumab once every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

RO7284755; Tecentriq

Eligibility Criteria

Inclusion Criteria

• Locally advanced/unresectable or metastatic disease
• No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments
• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
• Eastern Cooperative Oncology Group Performance Status 0 to 1
• Life expectancy of >=12 weeks
• Consent to provide an archival tumor tissue sample
• Adequate cardiovascular, hematological, coagulative, hepatic and renal function

Exclusion Criteria

• Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
• Untreated central nervous system (CNS) metastases
• Treated asymptomatic CNS metastases
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks before Cycle1 Day 1 (C1D1)
• Active or history of carcinomatous meningitis/leptomeningeal disease
• Uncontrolled tumor-related pain or symptomatic hypercalcemia
• Concurrent second malignancy
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration
• Active or uncontrolled infections
• Known HIV infection
• Hepatitis B virus (HBV) or hepatitis C virus infection
• Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade <=1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy
• Participants with bilateral pleural effusion
• Major surgery or significant traumatic injury < 28 days before study treatment administration or anticipation of the need for major surgery during study treatment
• Known allergy or hypersensitivity to any component of the formulations of the IMPs to be administered, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanized antibodies
• History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
• Previous treatment with Interleukin-2 (IL-2)/Interleukin-5 (IL-15)-like cytokines. IL-2/IL-15 use as an adjunct treatment component for adoptive cell therapy is permitted. In Part 3, patients who have received adoptive cell therapy such as tumor-infiltrating lymphocytes (TIL) are excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Cliniques Universitaires St-Luc

Brussels, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Herlev Hospital

Herlev, , Denmark

Rigshospitalet

København Ø, , Denmark

NKI/AvL

Amsterdam, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

Warsaw, , Poland

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital del Mar

Barcelona, , Spain

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

Barcelona, , Spain

Hospital Clinic Barcelona

Barcelona, , Spain

Countries

Belgium; Denmark; Netherlands; Poland; Spain

Other Identifiers

2019-004022-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-503749-76-00

Identifier Type: CTIS

Identifier Source: secondary_id

BP41628

Identifier Type: -

Identifier Source: org_study_id