NCT05848843

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lung Cancer
• Gastro-intestinal Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Given by vein (IV)
DRUG	Adagrasib	Given by PO

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2023-05-08
• Last updated: 2024-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study