OncoMatch/Clinical Trials/NCT05382559
A Study of ASP3082 in Adults With Advanced Solid Tumors
Is NCT05382559 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for solid tumor.
Treatment: Setidegrasib · Cetuximab · Leucovorin · Oxaliplatin · Fluorouracil · Irinotecan · Nanoparticle albumin-bound-paclitaxel · Gemcitabine · Docetaxel · Pembrolizumab · Cisplatin · Carboplatin · Pemetrexed · Liposomal Irinotecan — This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together 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 received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: KRAS G12D mutation
documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive standard approved therapies (no limit to the number of prior treatment regimens)
Cannot have received: KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D
Exception: Participants who received prior treatment with a KRAS G12D inhibitor/degrader are eligible for the ASP3082 combination therapy cohort.
Participant has received prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor/degrader are eligible for the ASP3082 combination therapy cohort.
Lab requirements
Blood counts
adequate organ function as indicated by protocol laboratory value parameters
Kidney function
adequate organ function as indicated by protocol laboratory value parameters
Liver function
adequate organ function as indicated by protocol laboratory value parameters
Cardiac function
LVEF < 50% as determined by MUGA or ECHO, or clinically significant cardiac disease, unstable angina, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome excluded; QTcF > 450 ms (men) or >470 ms (women) excluded
adequate organ function as indicated by protocol laboratory value parameters; LVEF < 50% as determined by MUGA or ECHO, or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome. QTcF > 450 ms (men) or >470 ms (women) during screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- UCLA Santa Monica Hematology Oncology · Santa Monica, California
- Denver HealthONE Drug Development Unit · Denver, Colorado
- Smilow Cancer Center at Yale New Haven Hospital · New Haven, Connecticut
- Georgetown University Hospital · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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