Clinical trialPhase 1Withdrawn
A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations
- Outcome
- Stopped early0 participant accrual (Enrollment)
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- 25 April 2023
- Expected end
- 16 January 2024
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
- Sponsor
- Other
- Results posted
- No
- Last update
- 23 January 2024
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Brief summary public domain (ClinicalTrials.gov)
To find a recommended dose of the combination of adagrasib and durvalumab that can be given to patients with cancers that have a KRAS G12C mutation.
Detailed description public domain (ClinicalTrials.gov)
Primary Objectives: • To determine the safety and tolerability, and to establish the recommended dose of the adagrasib and durvalumab combination in advanced NSCLC or GI cancer patients. Secondary Objectives: * To determine the objective response rate of the adagrasib and durvalumab combination for frontline treatment of advanced NSCLC harboring a KRAS G12C mutation. * To determine the objective response rate of the adagrasib and durvalumab combination for treatment of advanced CRC that have progressed on prior therapy with KRAS G12C inhibitors. * To determine duration of response (DOR) and progression-free survival (PFS) for the combination of the adagrasib and durvalumab in patients with advanced NSCLC harboring a KRAS G12C mutation. * To determine DOR and PFS for the combination of the adagrasib and durvalumab in patients with advanced CRC that have progressed on prior therapy with KRAS G12C inhibitors. Exploratory Objectives: * To assess predictive biomarkers of response and resistance to the combination of adagrasib and durvalumab. * To assess mechanisms of tumor cell adaptation upon treatment with the combination of adagrasib and durvalumab. * To determine mechanisms of acquired resistance to the combination of adagrasib and durvalumab. * To assess the effect of the combination of adagrasib and durvalumab on the immune tumor microenvironment. * To generate cell lines and patient derived xenograft (PDX) models from tumor samples. * To assess the anti-tumor reactivity of tumor infiltrating lymphocytes (TIL) from tumor biopsies.