Solid TumorsPhase 1NCT04857138
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
A Phase 1 study testing RO7300490 and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 11 sites in 5 countries.
Trial 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]… 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?
- RO7300490 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 18 May 2021to 18 Jan 2024
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Spain4 sites
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, 28027
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarre, 31008
United Kingdom3 sites
Western General Hospital; Edinburgh Cancer Center
Edinburgh, EH4 2XU
Guys and St Thomas Hospital; OHCT Clinical Trials
London, SE1 9RT
Christie Hospital NHS Trust; Experimental Cancer Medicine Team
Manchester, M20 4BX
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
About this study
Official title: An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
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
- Being tested
- RO7300490, Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7300490Drug
Participants will receive RO7300490, as described in the Arm Descriptions.
AtezolizumabDrug
Participants will receive Atezolizumab, as described in the Arm Descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: RO7300490; 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 (AEs) (Parts 1 and 2)
Measured: Up to 36 months
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)
Measured: Up to 36 months
Objective Response Rate (ORR) (Part 3)
Measured: Up to 48 months
Secondary outcomes (11)
Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)
Measured: Up to 48 months
Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)
Measured: Up to 48 months
Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)
Measured: Up to 48 months
Clearance (CL) of RO7300490 (Parts 1, 2 and 3)
Measured: Up to 48 months
Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)
Measured: Up to 48 months
Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3)
Measured: Up to 48 months
Objective Response Rate (ORR) (Parts 1 and 2)
Measured: Up to 48 months
Disease Control Rate (DCR) (Parts 1, 2 and 3)
Measured: Up to 48 months
Duration of Response (DOR) (Parts 1, 2 and 3)
Measured: Up to 48 months
Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3)
Measured: Up to 48 months
Percentage of Participants With Adverse Events (AEs) (Part 3)
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start18 May 2021
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT04857138
- Sponsor's protocol ID
- WP42627
- Other IDs
- 2020-004489-21
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Melero I, Reis B, Rusterholz C, Epp A, Kratochwil NA, Wu C, Hettich M, Kazantzidis G, Rieder N, Schwalie PC, Badillo S, Kumpesa N, Thommen A, Vugts DJ, Moreno V, Lostes Bardaji J, Alvarez EC, de Andrea CE, Spanggaard I, Lee DH, Spicer J, Thistlethwaite F, Oh DY, Hollebecque A, Cirovic O, Symeonides SN. Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial. Nat Cancer. 2026 May;7(5):840-856. doi: 10.1038/s43018-026-01157-8. Epub 2026 May 1.
PubMed 42067656
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04857138
- Acronym / sponsor ID
- WP42627
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 23 Apr 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation (RO7300490 Monotherapy) | Experimental | Drug: RO7300490Participants 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. |
| Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy) | Experimental | Drug: RO7300490, Drug: AtezolizumabParticipants 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. |
| Part 3: Dose Expansion (Disease-specific Expansion(s)) | Experimental | Drug: RO7300490, Drug: AtezolizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| RO7300490Participants will receive RO7300490, as described in the Arm Descriptions. | Drug | Part 1: Dose Escalation (RO7300490 Monotherapy), Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy), Part 3: Dose Expansion (Disease-specific Expansion(s)) |
| AtezolizumabParticipants will receive Atezolizumab, as described in the Arm Descriptions. | Drug | Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy), Part 3: Dose Expansion (Disease-specific Expansion(s)) |
Primary outcome
Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)
Time frame: Up to 36 months
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)
Time frame: Up to 36 months
Objective Response Rate (ORR) (Part 3)
Time frame: Up to 48 months
11 secondary outcomes
Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)
Time frame: Up to 48 months
Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)
Time frame: Up to 48 months
Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)
Time frame: Up to 48 months
Clearance (CL) of RO7300490 (Parts 1, 2 and 3)
Time frame: Up to 48 months
Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)
Time frame: Up to 48 months
Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3)
Time frame: Up to 48 months
Objective Response Rate (ORR) (Parts 1 and 2)
Time frame: Up to 48 months
Disease Control Rate (DCR) (Parts 1, 2 and 3)
Time frame: Up to 48 months
Duration of Response (DOR) (Parts 1, 2 and 3)
Time frame: Up to 48 months
Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3)
Time frame: Up to 48 months
Percentage of Participants With Adverse Events (AEs) (Part 3)
Time frame: Up to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 42067656Melero I, Reis B, Rusterholz C, Epp A, Kratochwil NA, Wu C, Hettich M, Kazantzidis G, Rieder N, Schwalie PC, Badillo S, Kumpesa N, Thommen A, Vugts DJ, Moreno V, Lostes Bardaji J, Alvarez EC, de Andrea CE, Spanggaard I, Lee DH, Spicer J, Thistlethwaite F, Oh DY, Hollebecque A, Cirovic O, Symeonides SN. Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial. Nat Cancer. 2026 May;7(5):840-856. doi: 10.1038/s43018-026-01157-8. Epub 2026 May 1.
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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
11 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 RO7300490 and Atezolizumab in people with Solid Tumors, run by Hoffmann-La Roche at 11 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, United Kingdom, South Korea, Denmark, France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (AEs) (Parts 1 and 2) (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857138, which also lists 1 linked publication.
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 5 Feb 2024.