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CompletedNCT04857138Updated Feb 5, 2024

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 interventional study of RO7300490 and Atezolizumab in Solid Tumors, sponsored by Hoffmann-La Roche. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

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Conditions studied

  • Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Part 1: Dose Escalation (RO7300490 Monotherapy)

    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.

    Drug: RO7300490

  • Experimental
    Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)

    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.

    Drug: RO7300490 · Drug: Atezolizumab

  • Experimental
    Part 3: Dose Expansion (Disease-specific Expansion(s))

    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.

    Drug: RO7300490 · Drug: Atezolizumab

Interventions

  • DrugRO7300490

    Participants will receive RO7300490, as described in the Arm Descriptions.

  • DrugAtezolizumab

    Participants will receive Atezolizumab, as described in the Arm Descriptions.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)

    Time frame: Up to 36 months

  2. Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)

    Time frame: Up to 36 months

  3. Objective Response Rate (ORR) (Part 3)

    Time frame: Up to 48 months

Secondary outcomes

  1. Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  2. Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  3. Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  4. Clearance (CL) of RO7300490 (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  5. Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  6. Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  7. Objective Response Rate (ORR) (Parts 1 and 2)

    Time frame: Up to 48 months

  8. Disease Control Rate (DCR) (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  9. Duration of Response (DOR) (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  10. Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3)

    Time frame: Up to 48 months

  11. Percentage of Participants With Adverse Events (AEs) (Part 3)

    Time frame: Up to 48 months

07

Study locations

11 sites
  • Rigshospitalet; Fase 1 Enhed - Onkologi
    København Ø, 2100, Denmark
  • Gustave Roussy
    Villejuif, 94805, France
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Clinica Universitaria de Navarra; Servicio de Oncologia
    Pamplona, Navarra 31008, Spain
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
    Barcelona, 08035, Spain
  • Clinica Universidad de Navarra Madrid; Servicio de Oncología
    Madrid, 28027, Spain
  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz
    Madrid, 28040, Spain
  • Western General Hospital; Edinburgh Cancer Center
    Edinburgh, EH4 2XU, United Kingdom
  • Guys and St Thomas Hospital; OHCT Clinical Trials
    London, SE1 9RT, United Kingdom
  • Christie Hospital NHS Trust; Experimental Cancer Medicine Team
    Manchester, M20 4BX, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04857138
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 23, 2021
Start date
May 18, 2021
Primary completion
Jan 18, 2024
Completion
Jan 18, 2024
Last update
Feb 5, 2024

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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