Clinical Trial 23599

• Overview

  Study Title:

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

  Summary:

  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, or cetuximab in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.

  Objective:

  Primary objectives: - To evaluate the safety and tolerability of BBO-11818 - Combination dose escalation only: To determine the recommended dose of BBO-11818 to be administered in combination with: Pembrolizumab +/- [cis/carboplatin + pemetrexed] in subjects with KRASG12D or KRASG12V mutant NSCLC Cetuximab in subjects with KRASG12D or KRASG12V mutant CRC Secondary objectives: - To evaluate preliminary antitumor activity of BBO-11818 monotherapy and in combination with: Pembrolizumab +/- [cis/carboplatin + pemetrexed] in subjects with KRASG12D or KRASG12V mutant NSCLC Cetuximab in subjects with KRASG12D or KRASG12V mutant CRC - To characterize the PK of BBO-11818

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; Non-covalent pan-KRAS inhibitor

  Medications:

  Alimta (Pemetrexed); BBO-11818 (); Cetuximab (); Erbitux (Cetuximab); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin (); cisplatin ()

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation, or KRAS-amplification
  • Measurable disease by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Malignancy within the last 2 years as specified in the protocol
  • Untreated brain metastases
  • Known hypersensitivity to BBO-11818 or its excipients
  • Other exclusions apply

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