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RecruitingLast updated: 2 February 2024

Genentech: The purpose of this study is to evaluate how safe, tolerable and effective a new cancer drug (RO7502175) is when given alone, and in combination with immunotherapy (atezolizumab), in adults with locally advanced or metastatic solid cancersA Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This is a phase I study that has two arms, and each arm has two stages. In the first stage of Arm A (dose escalation), successive cohorts of participants will receive escalating doses of RO7502175, administered by intravenous infusion (IV) on Day 1 of each 21-day cycle. This stage is seeking to determine the recommended dose level of RO7502175. In the second stage of Arm A (expansion), participants with certain types of solid cancers will receive the recommended dose level of RO7502175, as determined in the previous stage, which will be administered by IV infusion on Day 1 of each 21-day cycle. In the first stage of Arm B (dose escalation), successive cohorts of participants will receive escalating doses of RO7502175 plus with a fixed dose of atezolizumab, both given as IV infusions, on Day 1 of each 21-day cycle. This stage is seeking to determine the recommended dose of RO7502175 when given alongside atezolizumab. In the second stage of Arm B (expansion), participants with certain types of solid cancers will receive the recommended dose level of RO7502175, as determined in the previous stage, plus a fixed dose of atezolizumab, both as IV infusions, on Day 1 of each 21-day cycle. dose escalation and dose expansion study. Eligible participants will be allocated to receive either RO7502175 alone or in combination with immunotherapy (atezolizumab).

Conditions

This trial is treating patients with locally advanced, metastatic or recurrent solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

Genentech

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Trial Identifiers

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Trial sponsor

Genentech

Scientific Title

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  • Life expectancy at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
  • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
  • Tumor Specimen availability

Exclusion

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment
  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  • Active hepatitis B or C or tuberculosis
  • Positive test for human immunodeficiency virus (HIV) infection
  • Acute or chronic active Epstein-Barr virus (EBV) infection at screening
  • Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Active or history of autoimmune disease
  • Prior allogeneic stem cell or organ transplantation

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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