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| ID | Type | Description | Link |
|---|---|---|---|
| KONQUER-101 | Other Identifier | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
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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.
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, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a - Dose Escalation Monotherapy | Experimental | Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
|
| Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
|
| Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
|
| Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
|
| Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBO-11818 | Drug | Participants will receive assigned dose of BBO-11818 orally (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per RECIST v1.1 and CNS RECIST | approximately 5 years | |
| Clinical benefit rate (CBR) per RECIST v1.1 | approximately 5 years | |
| Duration of Response (DOR) per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria are specified in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | Contact | (650) 405-4770 | tbbo11818-101ct.gov@bbotx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute - West Los Angeles Office | Recruiting | Los Angeles | California | 90025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41790032 | Derived | Stahlhut C, Maciag AE, Sullivan KA, Singh K, Gitego N, Zhang Z, Chan AH, Sharma AK, Alexander PA, Shu J, Yang Y, Rigby M, Ma R, Setoodeh S, Smith BP, Pei J, Rabara D, Larsen EK, Turner DM, Zhang C, Feng C, Feng S, Stice JP, Xu R, Lin K, Stephen AG, Lightstone FC, Ji C, Wang K, Simanshu DK, Nissley DV, Wallace E, Wang B, Sinkevicius KW, McCormick F, Beltran PJ. Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants. Cancer Discov. 2026 Apr 1;16(4):740-759. doi: 10.1158/2159-8290.CD-25-1280. |
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Phase 1a: sequential/parallel, Phase 1b: parallel
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Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
|
| Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
|
| Cohort 1g - Dose Escalation Combination Therapy (Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
|
| Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
|
| Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
|
| Cohort 1j - Dose Escalation Combination Therapy (BBO-10203) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
|
| Cohort 2a - Dose Expansion Monotherapy | Experimental | Participants enrolled in this cohort will receive BBO-11818 as monotherapy |
|
| Cohort 2b - Dose Expansion Combination (Pembrolizumab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV) |
|
| Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV) |
|
| Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV) |
|
| Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV) |
|
| Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV) |
|
| Cohort 2g - Dose Expansion Combination Therapy (Cetuximab) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) |
|
| Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV) |
|
| Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV) |
|
| Cohort 2j - Dose Expansion Combination Therapy (BBO-10203) | Experimental | Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 |
|
| Pembrolizumab | Drug | Patients will receive IV pembrolizumab |
|
| Platinum chemotherapy (cisplatin or carboplatin) | Drug | Patients will receive IV platinum chemotherapy (cisplatin or carboplatin) |
|
| Pemetrexed | Drug | Patients will receive IV pemetrexed |
|
| Cetuximab | Drug | Patients will receive IV cetuximab |
|
| mFOLFOX6 | Drug | Patients may receive IV mFOLFOX6 |
|
| mFOLFOX6 | Drug | Patients will receive IV mFOLFOX6 |
|
| BBO-10203 | Drug | Participants will receive BBO-10203 orally (PO) |
|
| mFOLFIRINOX | Drug | Patients will receive IV mFOLFIRINOX |
|
| Gemcitabine | Drug | Patients will receive IV gemcitabine |
|
| Nab-paclitaxel | Drug | Patients will receive IV nab-paclitaxel |
|
| approximately 5 years |
| Progression-Free Survival (PFS) per RECIST v1.1 | approximately 5 years |
| Overall Survival (OS) | approximately 5 years |
| Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax) | approximately 5 years |
| Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax) | approximately 5 years |
| Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC) | approximately 5 years |
| University of California Davis | Recruiting | Sacramento | California | 95817 | United States |
|
| University of California San Diego Moores Cancer Center | Recruiting | San Diego | California | 92037 | United States |
|
| University of California San Francisco Helen Diller Family Comprehensive Cancer Center | Recruiting | San Francisco | California | 94158 | United States |
|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| OSF Healthcare Cancer Institute | Recruiting | Peoria | Illinois | 61637 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Sarah Cannon Research Institute at Mary Crowley | Recruiting | Dallas | Texas | 75230 | United States |
|
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D000068818 | Cetuximab |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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