The FDA has granted fast track designation to BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma, according to a news release from the developer, BridgeBio Oncology Therapeutics.1
BBO-11818 is a first-in-class, oral, non-covalent small molecule designed to target both the active and inactive states of the KRAS protein. Notably, the agent was developed to address the unmet need that currently remains in KRAS mutations KRASG12D and KRASG12V, in which therapies have not demonstrated the promising clinical efficacy that has been seen in KRASG12C mutations.
“Receiving fast track designation from the FDA for BBO-11818 in KRAS-mutant pancreatic ductal adenocarcinoma reflects the importance and urgency of accelerating the development of our pan-KRAS inhibitor in this serious disease,” stated Yong Ben, MD, the chief medical and development officer of BridgeBio Oncology Therapeutics, in the press release.1 “Pancreatic cancer remains one of the most difficult-to-treat malignancies. KRAS mutations are present in the vast majority of cases, yet patients have had few targeted options. This designation will help us collaborate closely with the FDA to advance BBO-11818 as efficiently as possible for patients who need new options.”
The agent is currently being evaluated in the phase 1 KONQUER-101 trial (NCT06917079) for patients with locally advanced unresectable or metastatic solid tumors harboring various KRAS mutations.
What efficacy and safety findings have been reported for BBO-11818?
Preliminary clinical activity for BBO-11818 was first highlighted in early 2026 based on data from the dose-escalation portion of the KONQUER-101 study.2 With a data cutoff of December 10, 2025, BBO-11818 achieved a partial response (PR) in 1 patient with pancreatic ductal adenocarcinoma who showed a 56% tumor reduction. Additionally, tumor reductions were observed in several other patients treated at higher dose levels.
Regarding safety, of 13 patients who received BBO-11818 monotherapy, treatment appeared “generally tolerable” with no observed dose-limiting toxicities and largely gastrointestinal-related treatment-related adverse events. Approximately dose-proportional exposure was observed with BBO-11818 at 600 mg twice daily, covering the G12Dand G12Valleles.
The developer plans to share updated phase 1 clinical data for BBO-11818 in the second half of 2026.
How is the KONQUER-101 trial structured?
The global, open-label, multi-center phase 1 KONQUER-101 trial was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BBO-11818. The study is divided into dose-escalation and dose-expansion phases. In the escalation phase, BBO-11818 is being tested as a monotherapy and in several combination cohorts. Treatment regimens include BBO-11818 administered in combination with pembrolizumab (Keytruda), cetuximab (Erbitux), or standard-of-care chemotherapy backbones.3 The dose-expansion phase will further investigate the treatment combinations. BBO-11818 is administered orally, with the dosing schedule and frequency determined by the specific cohort assignment within the escalation framework.
What patient eligibility criteria are required for KONQUER-101?
To be eligible for the KONQUER-101 trial, patients must have had histologically documented locally advanced and unresectable or metastatic solid tumors, including non–small cell lung cancer, pancreatic ductal adenocarcinoma, colorectal cancer, or other solid tumors. The trial specifically targets cancers with KRAS mutations, including the G12A, G12C, G12D, G12S, or G12V variants.
Patients were required to have measurable disease per RECIST v1.1 guidelines and an ECOG performance status of 0 or 1. Exclusion criteria included untreated brain metastases, a history of other malignancies within the last 2 years, or known hypersensitivity to the study drug or its excipients.
Additionally, BBO-11818 is being evaluated as monotherapy, in combination with standard-of-care therapies, and alongside BBO-10203, which is the developer’s RAS:PI3Kα breaker.
References
- BBOT granted U.S. FDA fast track designation for BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma. News release. BridgeBio Oncology Therapeutics. April 20, 2026. Accessed April 21, 2026. https://tinyurl.com/bva5mnc4
- BBOT announces new clinical data advancing its portfolio of three innovative and differentiated RAS and PI3Kα pipeline programs. News release. BridgeBio Oncology Therapeutics. January 7, 2026. Accessed April 21, 2026. https://tinyurl.com/5cdzpxwt
- BBO-11818 in adult subjects with KRAS mutant cancer. ClinicalTrials.gov. Updated March 23, 2026. Accessed April 21, 2026. https://tinyurl.com/3urzmrtj
