A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination with Anticancer Treatments in Participants with Solid Malignancies

MC #24-31

NCT #
not yet registered
Condition(s)
Breast Cancer, Colorectal Cancer, Lung Cancer (NSCLC)
Molecular Target(s)
PI3Ka:RAS Interaction
Drug Classification(s)
Protein-Protein Interaction Inhibitor
Agents(s)
BBO-10203
Phase(s)
I

Mechanism of Action

  • BBO-10203 modifies the catalytic α subunit of phosphoinositide 3-kinase (PI3Kα) thereby inhibiting its interaction with rat sarcoma vial oncogene homolog (RAS)

Purpose

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

  • How much of the study drug(s) can be given with an acceptable level of side effects
  • The effects of the study drug(s) (good and bad)
  • How much of the study drug(s) is absorbed into the blood and how fast it is removed
  • How the study drug(s) is acting on your body

Study Design

The study will consist of 2 parts – Dose Escalation and Dose Expansion. Your study doctor will inform you which part of the study you will be participating in.

Dose Escalation-Phase 1a:

  • Monotherapy Dose Escalation/Cohort Expansion: Participants enrolled in this cohort will receive BBO-10203 (different dose levels will be evaluated) once daily as monotherapy.
  • Combination Dose Escalation: Participants enrolled in this cohort will receive BBO-10203 (different dose levels) once daily in combination with Trastuzumab infusion (IV) or subcutaneous (SC)

Dose Expansion-Phase 1b:

  • BBO-10203 Combination Dose Expansion: Participants enrolled in this cohort will receive BBO-10203 once daily in combination with Trastuzumab IV/SC

Location

Mary Crowley Cancer Research - Medical City Dallas

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