Clinical Trial: NCT06917079
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
| Information Provided By: | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
| Last Update Posted: | 2026-06-02 |
Study Overview
Brief 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
Conditions
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
Intervention / Treatment
- Drug: BBO-11818
- Drug: Pembrolizumab
- Drug: Platinum chemotherapy (cisplatin or carboplatin)
- Drug: Pemetrexed
- Drug: Cetuximab
- Drug: mFOLFOX6
- Drug: mFOLFOX6
- Drug: BBO-10203
- Drug: mFOLFIRINOX
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
Other Study ID Numbers
- TBBO11818-101
- KONQUER-101
Start Date (Actual)
2025-03-31
Primary Completion Date (Estimated)
2027-08
Study Completion Date (Estimated)
2029-09
Enrollment (Estimated)
665
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
| Information Provided By: | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
| Last Update Posted: | 2026-06-02 |
Study Overview
Brief 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
Conditions
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
Intervention / Treatment
- Drug: BBO-11818
- Drug: Pembrolizumab
- Drug: Platinum chemotherapy (cisplatin or carboplatin)
- Drug: Pemetrexed
- Drug: Cetuximab
- Drug: mFOLFOX6
- Drug: mFOLFOX6
- Drug: BBO-10203
- Drug: mFOLFIRINOX
- Drug: Gemcitabine
- Drug: Nab-paclitaxel
Other Study ID Numbers
- TBBO11818-101
- KONQUER-101
Start Date (Actual)
2025-03-31
Primary Completion Date (Estimated)
2027-08
Study Completion Date (Estimated)
2029-09
Enrollment (Estimated)
665
Study Type
Interventional
Phase
Phase 1