Solid TumorsPhase 1NCT04303858
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
A Phase 1 study testing Eciskafusp Alfa and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Eciskafusp Alfa and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 4 May 2020to 2 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Spain4 sites
Hospital del Mar
Barcelona, 08003
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Clinic Barcelona
Barcelona, 08036
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Belgium2 sites
Cliniques Universitaires St-Luc
Brussels, 1200
UZ Leuven Gasthuisberg
Leuven, 3000
Netherlands2 sites
NKI/AvL
Amsterdam, 1066 CX
Erasmus MC
Rotterdam, 3015 GD
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, 02-781
About this study
Official title: An Open-Label, Multicenter, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumor Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
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.
Read the 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
- Being tested
- Eciskafusp Alfa, Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eciskafusp AlfaDrug
Also called RO7284755
Participants will be administered eciskafusp alfa in different schedules.
AtezolizumabDrug
Also called Tecentriq
Participants will be administered 1200 mg of atezolizumab once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Eciskafusp Alfa |
| Eciskafusp Alfa in Combination with Atezolizumab | Experimental | Part 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab. Receives: 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. Receives: Drug: Eciskafusp Alfa; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 28 months
Percentage of Partcipants with ADAs to Eciskafusp Alfa
Measured: Up to 28 months
Area Under the Curve (AUC) for Eciskafusp Alfa
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline
Percentage of Immune Cells with CD8+ PD1+ and CD8+ PD1+ TCF7+ Expression
Measured: Baseline
Blood Tumor Mutational Burden
Blood tumor mutational burden is defined as the number of genetic mutations per megabase (1,000,000 bases).
Measured: Baseline
Change from Baseline in Percentage of Immune Cell Subsets
Immune cells include NK, CD8, and Treg cells
Measured: 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...
Measured: Baseline to End of Treatment (up to approximately 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start4 May 2020
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Why it stopped: After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303858
- Sponsor's protocol ID
- BP41628
- Other IDs
- 2019-004022-25, 2023-503749-76-00, 2023, 2019
- Status last verified
- May 2026
- First submitted
- 9 Mar 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumor Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04303858
- Acronym / sponsor ID
- BP41628
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 4 May 2020 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eciskafusp Alfa as a Single Agent | Experimental | Drug: Eciskafusp AlfaPart 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. |
| Eciskafusp Alfa in Combination with Atezolizumab | Experimental | Drug: Eciskafusp Alfa, Drug: AtezolizumabPart 2: Dose-escalation of eciskafusp alfa in combination with atezolizumab. |
| Eciskafusp Alfa as a Single Agent and/or with Atezolizumab | Experimental | Drug: Eciskafusp Alfa, Drug: AtezolizumabPart 3: Extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eciskafusp AlfaAlso: RO7284755Participants will be administered eciskafusp alfa in different schedules. | Drug | Eciskafusp Alfa as a Single Agent, Eciskafusp Alfa as a Single Agent and/or with Atezolizumab, Eciskafusp Alfa in Combination with Atezolizumab |
| AtezolizumabAlso: TecentriqParticipants will be administered 1200 mg of atezolizumab once every 3 weeks. | Drug | Eciskafusp Alfa as a Single Agent and/or with Atezolizumab, Eciskafusp Alfa in Combination with Atezolizumab |
Primary outcome
Percentage of Participants with Adverse Events in Part 1 and Part 2
Time frame: From randomization until end of Part 1 and Part 2 (up to approximately 1.5 months)
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.
Percentage of Participants with Dose-Limiting Toxicities in Part 1 and Part 2
Time frame: From randomization up to day 14 (Part 1) or day 28 (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.
Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Part 3
Time frame: From start of extension phase until disease progression, drug discontinuation, withdrawal or death (up to approximately 26 months)
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).
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)
17 secondary outcomes
Investigator Assessed Objective Response Rate according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Parts 1 and 2
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
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
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
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
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
Time frame: Baseline
Change from Baseline in Percentage of Immune Cell Subsets
Time frame: Baseline to End of Treatment (up to approximately 28 months)
Change from Baseline in Percentage of Immune Markers
Time frame: Baseline to End of Treatment (up to approximately 28 months)
Results and safety
The study was stopped early (reason given: After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eciskafusp Alfa and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Belgium, Denmark, Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events in Part 1 and Part 2 (time frame: From randomization until end of Part 1 and Part 2 (up to approximately 1.5 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.