Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic, colorectal and non-small cell lung cancer
- fireflyannf
- Mar 30
- 2 min read
Updated: Apr 7
ESMO24 abstract
608O - Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)
Promising antitumour activity presented for emerging targets in different solid tumours
"A second phase I dose-escalation study investigated the clinical activity of the first-in-class KRAS G12D selective protein degrader ASP3082 in 111 patients with advanced pancreatic cancer, colorectal cancer and NSCLC and was shown to have an acceptable safety profile (Abstract 608O). The KRAS G12D mutation is present in more than one in three pancreatic cancers, about one in eight colorectal cancers, and in several other cancer types (Cancer Discov. 2022;12:924–937).
At the dose of ASP3082 300–600 mg intravenously once weekly (n=13), the ORR was 23.1% and the disease control rate (DCR) was 84.6% in NSCLC and 18.5% and 48.1%, respectively, in pancreatic ductal adenocarcinoma.
'Targeting the KRAS G12D mutation is generating tremendous interest as it occurs in several tumour types at high rates. The trial results are especially notable for those difficult-to-treat cancers such as pancreatic cancer for which encouraging responses were reported,' notes Siu."
KRAS G12D-Mutated Advanced Solid Tumors: First-in-Class Drug Shows Promising Safety and Clinical Activity
"Response results at data cutoff were particularly promising for patients with PDAC and NSCLC who received 300 to 600 mg of ASP3082 as follows: In the PDAC group, 6 of 27 participants remained on treatment, and five participants had partial responses, with a median time to response of 2.6 months. In the NSCLC group, 8 of 13 remained on treatment, and three participants had partial responses, with a median time to response of 1.4 months."
NCT05382559 Trial Link - 32 locations
recruiting in the US, Spain, France, Japan and Korea
"In Part 1, different small groups of people will receive lower to higher doses of ASP3082, alone or with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, alone or with cetuximab to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have taken ASP3082 (alone or with cetuximab) or until suitable doses have been selected for Part 2.
In Part 2, other different small groups of people will receive ASP3082, alone or with cetuximab, with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP3082 to use in future studies."
NOTE: All interventional trials involve risk. So please consult with your oncology tem as well as ask questions of the trial researchers.
FYI: posts in KRAS KICKERS’ Facebook group with additional information:
