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Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer and colorectal cancer.
Study details:
This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRAS (Kirsten rat sarcoma) G12C mutant non-small cell lung cancer and colorectal cancer. The study includes dose escalation phase and dose expansion phase.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-05-22
Primary completion: 2027-08-01
Study completion finish: 2028-02-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06343402
Intervention or treatment
DRUG: BBO-8520
DRUG: Pembrolizumab
Conditions
- • Non-small Cell Lung Cancer
- • Metastatic Non-Small Cell Lung Cancer
- • NSCLC
- • KRAS G12C
- • Colorectal Cancer
- • Metastatic Colorectal Cancer
- • Colon Cancer
- • Metastatic Lung Cancer
- • Advanced Lung Carcinoma
- • CRC
- • Advanced Colorectal Carcinoma
- • Metastatic Colon Cancer
Find a site
Closest Location:
Kinghorn Cancer Centre
Research sites nearby
Select from list below to view details:
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Peninsula & South Eastern Hematology and Oncology Group (PAS)
Frankston, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cohort 1a - Dose Escalation/Dose Finding Monotherapy
| DRUG: BBO-8520
|
EXPERIMENTAL: Cohort 1b - Dose Escalation/Dose Finding Combination Therapy
| DRUG: BBO-8520
|
EXPERIMENTAL: Cohort 2a - Dose Expansion Monotherapy
| DRUG: BBO-8520
|
EXPERIMENTAL: Cohort 2b - Dose Expansion Combination Therapy
| DRUG: BBO-8520
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Adverse Events | Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | approximately 3 years |
| Dose-limiting toxicities (DLTs) | Number of participants with dose limiting toxicities | approximately 3 years |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| To evaluate preliminary antitumor activity of BBO-8520 | Progression-free survival (PFS) per (RECIST v1.1) | approximately 3 years |
| To evaluate preliminary antitumor activity of BBO-8520 | Duration of response (DOR) per (RECIST v1.1) | approximately 3 years |
| Overall Survival (OS) | Not Specified | approximately 3 years |
| To characterize the pharmacokinetics (PK) of BBO-8520 | Area under the curve (AUC) | approximately 3 years |
| To characterize the pharmacokinetics (PK) of BBO-8520 | Peak plasma drug concentration (Cmax) | approximately 3 years |
| To characterize the pharmacokinetics (PK) of BBO-8520 | Time to Cmax (Tmax) | approximately 3 years |
| To characterize the pharmacokinetics (PK) of BBO-8520 | Half life (T1/2) | approximately 3 years |
Frequently Asked Questions
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