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RecruitingLast updated: 8 April 2024

ONKORAS-101: This study is evaluating a 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

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 patients with KRAS G12C mutant non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I

Trial Acronym

ONKORAS-101

More information

Trial Identifiers

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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

Eligibility

Inclusion

  • 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

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 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

Other inclusion/exclusion criteria may apply

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

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