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Completed

NCT Number: NCT04857138

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 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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rigshospitalet; Fase 1 Enhed - Onkologi, København Ø, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

RO7300490

Drug

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

Atezolizumab

Drug

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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2021
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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