A Phase 1 interventional study of Eciskafusp Alfa and Atezolizumab in Solid Tumors, sponsored by Hoffmann-La Roche. Terminated at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
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).
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab.
Drug: Eciskafusp Alfa · Drug: Atezolizumab
Part 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab.
Drug: Eciskafusp Alfa · Drug: Atezolizumab
Participants will be administered eciskafusp alfa in different schedules.
Also known as: RO7284755
Participants will be administered 1200 mg of atezolizumab once every 3 weeks.
Also known as: Tecentriq
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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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 Parts 1 and 2
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).
Time frame: 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
An 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.
Time frame: From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)
Disease Control Rate in Part 3
The disease control rate was defined as proportion of participants being either responder or in 'stable disease' (SD). To classify a response as SD, measurements will have to be classified as stable (according to RECIST v1.1) at least once at a minimum of 4 weeks after study entry.
Time frame: From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)
Duration of Response in Part 3
Duration of response will be calculated for 'responder' participants (i.e. best \[confirmed\] overall response of CR or PR) and will be defined as the time from first occurrence of a documented response until the time of documented disease progression or death (death within 30 days from last study treatment) from any cause, whichever occurs first.
Time frame: 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
Progression-free survival was defined as the time from first dose of study treatment to the first occurrence of documented disease progression (based on RECIST 1.1 Investigator's assessment) or death from any cause, whichever occurs first.
Time frame: From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)
Change from Baseline in Antidrug Antibody (ADA) to Eciskafusp Alfa
Time frame: Up to 28 months
Percentage of Partcipants with ADAs to Eciskafusp Alfa
Time frame: Up to 28 months
Area Under the Curve (AUC) for Eciskafusp Alfa
Time frame: Predose, C1 Days 1, 2, 3, 5, 8, 9, 10, 12, 15, 16, 17, and 19; C2 Days 1, 2, 8, 9, 10, 12, 15, and 16; C3 Days 1, 2, 3, and 8; C4 Days 1 and 2; C5 Days1, 2, and 8; and days 1 and 2 for any subsequent cycles (Up to 28 months)
Minimum Concentration (Cmin) for Eciskafusp Alfa
Time frame: Predose, C1 Days 1, 2, 3, 5, 8, 9, 10, 12, 15, 16, 17, and 19; C2 Days 1, 2, 8, 9, 10, 12, 15, and 16; C3 Days 1, 2, 3, and 8; C4 Days 1 and 2; C5 Days1, 2, and 8; and days 1 and 2 for any subsequent cycles (Up to 28 months)
Maximum Concentration (Cmax) for Eciskafusp Alfa
Time frame: Predose, C1 Days 1, 2, 3, 5, 8, 9, 10, 12, 15, 16, 17, and 19; C2 Days 1, 2, 8, 9, 10, 12, 15, and 16; C3 Days 1, 2, 3, and 8; C4 Days 1 and 2; C5 Days1, 2, and 8; and days 1 and 2 for any subsequent cycles (Up to 28 months)
Clearance (CL) for Eciskafusp Alfa
Time frame: Predose, C1 Days 1, 2, 3, 5, 8, 9, 10, 12, 15, 16, 17, and 19; C2 Days 1, 2, 8, 9, 10, 12, 15, and 16; C3 Days 1, 2, 3, and 8; C4 Days 1 and 2; C5 Days1, 2, and 8; and days 1 and 2 for any subsequent cycles (Up to 28 months)
Volume of Distribution at Steady-State Conditions (Vss) for Eciskafusp Alfa
Time frame: Predose, C1 Days 1, 2, 3, 5, 8, 9, 10, 12, 15, 16, 17, and 19; C2 Days 1, 2, 8, 9, 10, 12, 15, and 16; C3 Days 1, 2, 3, and 8; C4 Days 1 and 2; C5 Days1, 2, and 8; and days 1 and 2 for any subsequent cycles (Up to 28 months)
Percentage of Immune and Tumor Cells with Positive Programmed Cell Death-1 (PD-1) and Programmed Cell Death-Ligand 1 (PD-L1) Expression in the Tumor Microenvironment (TME)
Time frame: Baseline
Percentage of Immune Cells with CD8+ PD1+ and CD8+ PD1+ TCF7+ Expression
Time frame: Baseline
Blood Tumor Mutational Burden
Blood tumor mutational burden is defined as the number of genetic mutations per megabase (1,000,000 bases).
Time frame: Baseline
Change from Baseline in Percentage of Immune Cell Subsets
Immune cells include NK, CD8, and Treg cells
Time frame: Baseline to End of Treatment (up to approximately 28 months)
Change from Baseline in Percentage of Immune Markers
Immune markers include PD-1, PD-L1, sCD25, cytokines, etc...
Time frame: Baseline to End of Treatment (up to approximately 28 months)
Plan to share: No
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