Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Details

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.

Keywords

Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma, CRC (Colorectal Cancer), Metastatic Non-Small Lung Cell Cancer, Metastatic Colorectal Cancer (CRC), KRAS G12A, KRAS G12C, KRAS G12D, KRAS G12S, KRAS G12V, Metastatic Pancreatic Ductal Adenocarcinoma, Advanced Lung Carcinoma, Solid Tumor, Adult, BBOT, BridgeBio Oncology Therapeutics, Phase1, Phase 1a/1b, CRC, PDAC, Metastatic Cancer, Advanced Cancer, Pembrolizumab, Cetuximab, Platinum Chemotherapy, Pemetrexed, KONQUER, KONQUER-101, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Neoplasm Metastasis, Cisplatin, Carboplatin, BBO-11818, Platinum chemotherapy (cisplatin or carboplatin)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Malignancy within the last 2 years as specified in the protocol
  • Untreated brain metastases
  • Known hypersensitivity to BBO-11818 or its excipients

Other inclusion/exclusion criteria are specified in the protocol.

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego 5391811 California 5332921 92037 United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City 5780993 Utah 5549030 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
ID
NCT06917079
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 287 study participants
Last Updated