A Phase 1 Study of KQB198 Alone and With Osimertinib in People With Non-Small Cell Lung Cancer

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Full Title

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies

Purpose

Researchers want to find the best dose of KQB198 to use alone and with osimertinib to treat advanced lung cancer. The people in this study have non-small cell lung cancer (NSCLC) that has spread. In addition, their cancers have a change (mutation) in the NRAS, KRAS, HRAS, EGFR, NF1, SHP2, or SOS1 gene. These mutations can cause cancer cells to grow.

KQB198 blocks the SOS1 protein, which is found on cancer cells and plays a role in cancer growth and survival. By blocking this protein, KQB198 may help slow or stop the growth of your cancer. KQB198 and osimertinib are both taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have NSCLC that has spread and has a mutation in the NRAS, KRAS, HRAS, EGFR, NF1, SHP2, or SOS1 gene.
  • Have recovered from the serious side effects of prior anti-cancer therapies before getting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Helena Yu’s office at 646-608-3912.

Protocol

24-263

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06507306