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NCT Number: NCT06537310

A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer-Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female participants aged ≥18 years
  • Body weight > 40 kilograms (kg)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
  • Participants with advanced and/or metastatic solid tumors
  • Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
  • Negative serum pregnancy test
  • Participants must have adequate cardiovascular, hematological, liver and renal function.

Exclusion criteria

  • Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
  • Active second malignancy within 2 years prior to screening
  • History or current clinically significant cardiovascular/cerebrovascular disease
  • Active or history of autoimmune disease
  • Serious, uncontrolled infection
  • Known clinically significant liver disease
  • Unresolved acute toxicity > grade 1 from prior therapy

Treatment and study plan

RO7567132 and Atezolizumab

Drug

RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Time frame: Up to a maximum of 27 months

  2. Percentage of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: From baseline to 3 weeks on study

Secondary outcomes

  1. Maximum Concentration (Cmax) Derived for RO7567132

    Time frame: Up to a maximum of 24 months

  2. Time of Maximum Concentration (Tmax)

    Time frame: Up to a maximum of 24 months

  3. Minimum Concentration (Cmin)

    Time frame: Up to maximum of 24 Months

  4. Clearance (CL) or Apparent Clearance (CL/F)

    Time frame: Up to a maximum of 24 months

  5. Volume of Distribution at Steady State (Vss)

    Time frame: Up to a maximum of 24 months

  6. Area Under the Curve (AUC) for Various Time Intervals

    Time frame: Up to a maximum of 24 months

  7. Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132

    Time frame: Up to 24 months

  8. Objective Response Rate (ORR)

    Time frame: Up to a maximum of 24 months

  9. Disease Control Rate (DCR)

    Time frame: Up to a maximum of 24 months

  10. Duration of Response (DoR)

    Time frame: Up to a maximum of 24 months

  11. Progression Free Survival (PFS)

    Time frame: Up to a maximum of 24 months

  12. Overall Survival (OS)

    Time frame: Up to a maximum of 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
Jul 13, 2026

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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