A Phase 1 Study of RO7623066 Alone and in Combination in Patients with Advanced Solid Tumors

MC #23-01

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
RO7623066
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
RO7623066
Phase(s)
I

Mechanism of Action

RO7623066 is a potent, selective small molecule inhibitor of USP1 that is being developed for the treatment of solid tumors.

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study drug can be given with an acceptable level of side effects alone and in combination with Olaparib or Carboplatin
  • The effects of the study drug (good and bad) alone and in combination with Olaparib or Carboplatin
  • How much of the study drug / agent is absorbed into the blood and how fast it is removed
  • How the study drug is acting on your body
  • If research tests can be used in the future to predict who will benefit from RO7623066 alone or in combination with Olaparib or Carboplatin

Study Design

This study will be done in 3 parts.  The first part is dose escalation, and the second part is dose expansion.

Dose Escalation means that the amount of the study drug given will be increased in each group of research participants, to find the most appropriate dose for further study.

In the Dose Expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.  While study parts 1 and 2 will be carried out at all sites, only selected sites will participate in part 3.  Hence, the dose of the study drug and whether you receive it alone or with a combination drug will be determined by when and where you enroll on the study and the type of cancer you have; you will either be in dose escalation, or dose expansion or the Food Effect Cohort.

Location

Mary Crowley Cancer Research - Medical City Dallas

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