ClinTrial Refer

Trial Acronym
TBBO8520-101

Registration Number
NCT06343402

Scientific Title
A Phase 1a/1b Open-Label Study of BBO-8520 Monotherapy and BBO-8520 in Combination With Pembrolizumab in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

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

Histologically documented locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation
Measurable disease by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Patients with malignancy within the last 2 years as specified in the protocol
Patients with untreated brain metastases
Patients with known hypersensitivity to BBO-8520 or its excipients
For Cohorts 2a and 2b:
Patients with a known hypersensitivity to pembrolizumab or its excipients
Patients with active autoimmune disease of history of autoimmune disease that might recur
Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Trial Location Name

Address

Status

The Queen Elizabeth Hospital (Haematology and Oncology)

28 Woodville Rd, Woodville South SA 5011, Australia

Recruiting

Primary Contact : Pamela Cooper, Pamela.cooper@sa.gov.au , 08 8222 6410

Secondary Contact : Tamara Olszowka, Tamara.Olszowka@sa.gov.au , 08 8222 8011

The Ras, Inc

Website URL

Link Name

Link URL

ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06343402?term=TBBO8520-101&limit=10&rank=1

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 1

Minimum Age
18

Maximum Age
100

Date Registered
11/09/2024

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral,Primary Care or GP Referral

Mutation Status and Biomarker
N/A

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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