Actively Recruiting
A Study of ASP3082 in Adults With Advanced Solid Tumors
Led by Astellas Pharma Inc · Updated on 2026-04-14
681
Participants Needed
53
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ASP3082 in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced (unresectable) or metastatic solid tumors with documented KRAS G12D mutation
- Participants who have received prior standard therapy with no further clinical benefit or are ineligible for approved therapies
- Participants with solid tumors allowed in ASP3082 monotherapy escalation cohorts; only KRAS G12D mutation included
- For combination therapy cohorts, participants must have metastatic pancreatic ductal adenocarcinoma (mPDAC) untreated by chemotherapy or with recurrence at least 6 months after prior therapy
- Consent to provide tumor samples before and during treatment as per protocol
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for dose escalation; 0 or 1 for dose expansion
- Last dose of prior antineoplastic therapy at least 21 days or 5 half-lives before study start
- Completed radiotherapy at least 14 days before study with recovery from toxicity and no active radiation pneumonitis
- Adverse events from prior therapy improved to grade 1 or baseline within 14 days before study or standard chemotherapy start
- Adequate organ function per protocol lab values, with labs drawn at least 14 days after any blood transfusion
- Female participants must not be pregnant and either not be women of childbearing potential or agree to contraception according to guidelines
- Female participants must agree not to breastfeed or donate ova during and 6 months after treatment
- Male participants with female partners of childbearing potential must agree to use contraception during and 3 months after treatment and not donate sperm
- Male participants with pregnant partners must agree to abstain or use condoms during pregnancy and 3 months after treatment
- Agree not to participate in another interventional study during study intervention (follow-up allowed)
You will not qualify if you...
- Received investigational therapy within 21 days or 5 half-lives before study start
- Symptomatic or untreated central nervous system (CNS) metastases; asymptomatic treated CNS metastases allowed
- Leptomeningeal disease from current malignancy
- Active prior malignancy within 2 years requiring treatment, except certain local cancers
- Known or suspected hypersensitivity to ASP3082 or its components
- Active hepatitis B or hepatitis C infection; HCV RNA testing not required if antibody negative
- Known HIV infection
- Recent myocardial infarction or unstable angina within 6 months; left ventricular ejection fraction below 50%; uncontrolled heart conditions
- Corrected QT interval (QTcF) above 450 ms (men) or 470 ms (women) during screening
- Prior treatment with KRAS G12D or pan-RAS inhibitors (except eligible for combination therapy cohort)
- Active infection requiring intravenous antibiotics within 14 days prior to study
- Expected need for other antineoplastic therapy during study
- Any condition making participation unsuitable including psychiatric or social issues
- Major surgery within 4 weeks prior to first dose
- For combination therapy: prior discontinuation of cetuximab due to toxicity or intolerance
- History of interstitial lung disease requiring systemic steroids; resolved pulmonary infections or radiation pneumonitis allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA Santa Monica Hematology Oncology
Santa Monica, California, United States, 90404
Actively Recruiting
3
Denver HealthONE Drug Development Unit
Denver, Colorado, United States, 80218
Actively Recruiting
4
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, United States, 06520-8028
Actively Recruiting
5
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
6
University of Florida, Davis Cancer Center
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Florida Cancer Specialist
Lake Mary, Florida, United States, 32746
Actively Recruiting
8
Florida Cancer Specialists & Research Institute Sarasota
Sarasota, Florida, United States, 34232-6422
Actively Recruiting
9
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
10
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
15
Columbia University - Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
Case Western
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
19
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Terminated
20
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
21
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
22
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
23
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
24
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
25
Fudan University Shanghai Cancer Center
Xuhui District, Shanghai Municipality, China
Actively Recruiting
26
Site FR33003
La Tronche, Grenobele, France
Actively Recruiting
27
Site FR33002
Bordeaux, France
Actively Recruiting
28
Site FR33001
Lyon, France
Actively Recruiting
29
Site FR33005
Lyon, France
Actively Recruiting
30
Site FR33004
Villejuif, Île-de-France Region, France
Actively Recruiting
31
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Actively Recruiting
32
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Actively Recruiting
33
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Actively Recruiting
34
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
35
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Actively Recruiting
36
Tohoku University Hospital
Sendai, Miyagi, Japan
Actively Recruiting
37
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Actively Recruiting
38
Kindai University Hospital
Sayama, Osaka, Japan
Actively Recruiting
39
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Actively Recruiting
40
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Actively Recruiting
41
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Actively Recruiting
42
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Actively Recruiting
43
Osaka International Cancer Institute
Osaka, Japan
Actively Recruiting
44
PanOncology Trials
San Juan, Puerto Rico, 00935
Actively Recruiting
45
Site KR82005
Goyang-si, Gyeonggi-do, South Korea
Actively Recruiting
46
Site KR82002
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
47
Site KR82001
Jongno -Gu, Seoul, South Korea
Actively Recruiting
48
Site KR82003
Seodaemun-gu, Seoul, South Korea
Actively Recruiting
49
Site KR82004
Songpa-gu, Seoul, South Korea
Actively Recruiting
50
Site ES34001
Barcelona, Spain
Actively Recruiting
51
Site ES34004
Madrid, Spain
Actively Recruiting
52
Site ES34002
Málaga, Spain
Actively Recruiting
53
Site ES34003
Seville, Spain
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here