OncoMatch/Clinical Trials/NCT05382559
A Study of ASP3082 in Adults With Advanced Solid Tumors
Is NCT05382559 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Tumor Agnostic
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS g12d
locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation
Excluded: KRAS other g12 mutations
Participants with other known KRAS G12 mutations will not be eligible for the study
Disease stage
Required: Stage III, IV, UNRESECTABLE STAGE IIIB-IV
locally advanced (unresectable) or metastatic solid tumor malignancy; pathologically documented locally advanced or metastatic (unresectable Stage IIIB-IV) NSCLC
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
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.
Cannot have received: cetuximab (cetuximab)
Exception: Prior discontinuation due to toxicity or intolerance
Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.
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
left ventricular ejection fraction (LVEF) < 50% as determined by MUGA scan 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; corrected QT interval (single ECG) using Fridericia's formula (QTcF) > 450 msec (men) or >470 msec (women) during screening.
Participant has adequate organ function as indicated by protocol laboratory value parameters... Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) < 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (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. Participant has a corrected QT interval (single electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 450 milliseconds (msec) (men) or >470 msec (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 →Frequently asked questions
Is NCT05382559 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D, cetuximab disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS g12d is a required biomarker for enrollment.
Are patients with KRAS alterations eligible?
No. KRAS other g12 mutations is an exclusion criterion.
What disease stage is eligible?
Stage III or IV or UNRESECTABLE STAGE IIIB-IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify