BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Pembrolizumab: Patients will receive IV pembrolizumab

Platinum chemotherapy (cisplatin or carboplatin): Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

Pemetrexed: Patients will receive IV pemetrexed

Cetuximab: Patients will receive IV cetuximab

mFOLFOX6: Patients may receive IV mFOLFOX6

mFOLFOX6: Patients will receive IV mFOLFOX6

BBO-10203: Participants will receive BBO-10203 orally (PO)

mFOLFIRINOX: Patients will receive IV mFOLFIRINOX

Gemcitabine: Patients will receive IV gemcitabine

Nab-paclitaxel: Patients will receive IV nab-paclitaxel

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) — approximately 5 years
• Determine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 — approximately 5 years

Trial sites (17)