A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Detailed description

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Arms & interventions

• DrugBBO-11818

  Participants will receive assigned dose of BBO-11818 orally (PO)

• DrugPembrolizumab

  Patients will receive IV pembrolizumab

• DrugPlatinum chemotherapy (cisplatin or carboplatin)

  Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

• DrugPemetrexed

  Patients will receive IV pemetrexed

• DrugCetuximab

  Patients will receive IV cetuximab

• DrugmFOLFOX6

  Patients may receive IV mFOLFOX6

• DrugmFOLFOX6

  Patients will receive IV mFOLFOX6

• DrugBBO-10203

  Participants will receive BBO-10203 orally (PO)

• DrugmFOLFIRINOX

  Patients will receive IV mFOLFIRINOX

• DrugGemcitabine

  Patients will receive IV gemcitabine

• DrugNab-paclitaxel

  Patients will receive IV nab-paclitaxel

Outcome measures

Eligibility criteria