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

NCT04303858 | Completed Phase 1

• 3 other identifiers: BP416282019-004022-252023-503749-76-00
• Study Type: interventional
• Target: 189
• Locations: 5 countries
• Sites: 12

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants with Adverse Events in Part 1 and Part 2

  An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  From randomization until end of Part 1 and Part 2 (up to approximately 1.5 months)

• Percentage of Participants with Dose-Limiting Toxicities in Part 1 and Part 2

  A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 5) or significant laboratory abnormality that occur during the DLT assessment periods, during Part 1 and Part 2 only, and is considered by the Investigator to be related to eciskafusp alfa or to the combination of eciskafusp alfa and atezolizumab. In Part 2, expected toxicities that are, in the opinion of the Investigator, entirely attributable to atezolizumab, will not be considered DLTs.

  From randomization up to day 14 (Part 1) or day 28 (Part 2)

• Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Part 3

  Objective response rate (ORR) was defined as the percentage of participants with investigator-assessed objective response of complete response (CR) or partial response (PR). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).

  From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)

• Recommended Dose for Extension (RDE) of Eciskafusp Alfa in Parts 1 and 2

  From randomization up to day 14 (Part 1) or day 28 (Part 2)

Secondary Outcomes (17)

• Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Parts 1 and 2

  From randomization until end of Part 1 and Part 2 (up to approximately 1.5 months)

• Percentage of Participants with Adverse Events in Part 3

  From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)

• Disease Control Rate in Part 3

  From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)

• Duration of Response in Part 3

  From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)

• Progression-free survival (PFS) in Part 3

  From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)

Study Arms (3)

Eciskafusp Alfa as a Single Agent

EXPERIMENTAL

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.

Drug: Eciskafusp Alfa

Eciskafusp Alfa in Combination with Atezolizumab

EXPERIMENTAL

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

Drug: Eciskafusp Alfa; Drug: Atezolizumab

Eciskafusp Alfa as a Single Agent and/or with Atezolizumab

EXPERIMENTAL

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

Drug: Eciskafusp Alfa; Drug: Atezolizumab

Interventions

Eciskafusp Alfa DRUG

Participants will be administered eciskafusp alfa in different schedules.

Also known as: RO7284755

Eciskafusp Alfa as a Single Agent; Eciskafusp Alfa as a Single Agent and/or with Atezolizumab; Eciskafusp Alfa in Combination with Atezolizumab

Atezolizumab DRUG

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

Also known as: Tecentriq

Eciskafusp Alfa as a Single Agent and/or with Atezolizumab; Eciskafusp Alfa in Combination with Atezolizumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

NKI/AvL

Amsterdam, 1066 CX, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

atezolizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: May 4, 2020
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2); ES (4); DK (2); BE (2); NL (2)