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RecruitingLast updated: 19 December 2025

ONKORAS-101: Targeted therapy (called BBO-8520) when given alone or in combination with immunotherapy in people with advanced non-small cell lung cancer with KRASG12C mutationA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

ONKORAS-101

Clinical summary

Summary

This study has two phases: Dose Escalation/Dose Finding, and Dose Expansion. 

In the Dose Escalation/Dose Finding stage, participants will be assigned to one of two cohorts. Both cohorts will evaluate different dose levels of BBO-8520.

  • Cohort 1a - participants will receive BBO-8520 once a day orally.
  • Cohort 1b - participants will receive BBO-8520 once a daily, orally, in combination with pembrolizumab immunotherapy which will be administered as an intravenous (IV) infusion.

In the Dose Expansion stage, participants will be assigned to one of two cohorts.

  • Cohort 2a - participants will receive BBO-8520 once a daily, orally.
  • Cohort 2b - participants will receive BBO-8520 once a day, orally, in combination with pembrolizumab via IV infusion.

 

Conditions

This trial is treating people with KRAS G12C mutant non-small cell lung cancer

Eligibility

Inclusion

  • Histologically documented locally advanced and unresectable 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

Exclusion

  • 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 1b 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

Other inclusion/exclusion criteria may apply

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

  • NCT06343402 *
  • THERAS_BRIDGEBIO_TBBO8520-101; TBBO8520-101

Trial sponsor

TheRas, Inc

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

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