A Study of ASP3082 in Adults With Advanced Solid Tumors
NCT ID: NCT05382559
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
651 participants
INTERVENTIONAL
2022-06-08
2026-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ASP3082 Dose Escalation (Monotherapy Part 1)
Participants will receive ASP3082 in a 21-day cycle.
ASP3082
Intravenous Infusion
ASP3082 Dose Expansion (Monotherapy Part 2)
Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
ASP3082
Intravenous Infusion
ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)
Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.
ASP3082
Intravenous Infusion
Cetuximab
Intravenous Infusion
ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)
Participants will receive ASP3082 or ASP3082 + Cetuximab with dose level(s) selected from dose escalation (part 1) in a 21-day cycle. Cetuximab will be administered weekly.
ASP3082
Intravenous Infusion
Cetuximab
Intravenous Infusion
ASP3082 China Safety Cohort
Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.
ASP3082
Intravenous Infusion
Treatment naive PDAC cohort ASP3082 + FOLFIRINOX
Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with FOLFIRINOX (leucovorin \[LV\]/fluorouracil \[5-FU\]/irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
ASP3082
Intravenous Infusion
Leucovorin
Intravenous Infusion
Oxaplatin
Intravenous Infusion
Fluorouracil
Intravenous Infusion
Irinotecan
Intravenous Infusion
Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + Gemcitabine
Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with Nab-P + GEM (nanoparticle albumin-bound-paclitaxel plus gemcitabine) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
ASP3082
Intravenous Infusion
Nanoparticle albumin-bound-paclitaxel
Intravenous Infusion
Gemcitabine
Intravenous Infusion
ASP3082 + Docetaxel - NSCLC
Participants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.
ASP3082
Intravenous Infusion
Docetaxel
Intravenous Infusion
ASP3082 + Pembrolizumab - NSCLC
Participants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.
ASP3082
Intravenous Infusion
Pembrolizumab
Intravenous Infusion
ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLC
Participants with KRAS G12D mutant will receive ASP3082 in combination with platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed, with or without pembrolizumab in a 21-day cycle.
ASP3082
Intravenous Infusion
Pembrolizumab
Intravenous Infusion
Cisplatin
Intravenous Infusion
Carboplatin
Intravenous Infusion
Pemetrexed
Intravenous Infusion
Interventions
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ASP3082
Intravenous Infusion
Cetuximab
Intravenous Infusion
Leucovorin
Intravenous Infusion
Oxaplatin
Intravenous Infusion
Fluorouracil
Intravenous Infusion
Irinotecan
Intravenous Infusion
Nanoparticle albumin-bound-paclitaxel
Intravenous Infusion
Gemcitabine
Intravenous Infusion
Docetaxel
Intravenous Infusion
Pembrolizumab
Intravenous Infusion
Cisplatin
Intravenous Infusion
Carboplatin
Intravenous Infusion
Pemetrexed
Intravenous Infusion
Eligibility Criteria
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Inclusion Criteria
* For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled.
* For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy.
* Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but not more than 56 days prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor/study medical monitor.
* Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
* Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.
* Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent \[defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone\] is permitted), and not have active radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<= 2 weeks of radiotherapy) to non-central nervous system disease.
* Participant's adverse events \[AEs\] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention.
* Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>= 14 days after any blood transfusion.).
* Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
* Not a woman of childbearing potential (WOCBP).
* WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.
* Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after study intervention administration.
* Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after study intervention administration.
* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 3 months after study intervention administration.
* Male participant must not donate sperm during the treatment period and for 3 months after study intervention administration.
* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 3 months after study intervention administration.
* Participant agrees not to participate in another interventional study while receiving study intervention (Participants who are currently in the follow-up period of an interventional clinical trial are allowed).
Exclusion Criteria
* Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.
* Participant has leptomeningeal disease as a manifestation of the current malignancy.
* Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.
* Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
* Participant with active hepatitis B (including acute hepatitis B virus \[HBV\] or chronic HBV) or hepatitis C virus \[HCV\] (ribonucleic acid \[RNA\] detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.
* Participant has a known history of human immunodeficiency virus \[HIV\] infection. No HIV testing is required unless mandated by a local health authority.
* 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.
* 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.
* Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
* Participant is expected to require another form of antineoplastic therapy while on study treatment.
* Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness/social situations that would limit compliance with study requirements).
* Participant has had major surgery within 4 weeks prior to first dose of study intervention.
For ASP3082 Combination Therapy:
* Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.
* History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Inc
Locations
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City of Hope National Medical Center
Duarte, California, United States
UCLA Santa Monica Hematology Oncology
Santa Monica, California, United States
Denver HealthONE Drug Development Unit
Denver, Colorado, United States
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Florida, Davis Cancer Center
Gainesville, Florida, United States
Florida Cancer Specialist
Lake Mary, Florida, United States
Florida Cancer Specialists & Research Institute Sarasota
Sarasota, Florida, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University - Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Case Western
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Xuhui District, Shanghai Municipality, China
Site FR33003
La Tronche, Grenobele, France
Site FR33002
Bordeaux, , France
Site FR33001
Lyon, , France
Site FR33005
Lyon, , France
Site FR33004
Villejuif, Île-de-France Region, France
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Osaka International Cancer Institute
Osaka, , Japan
Site KR82002
Seongnam-si, Gyeonggi-do, South Korea
Site KR82001
Jongno -Gu, Seoul, South Korea
Site KR82003
Seodaemun-gu, Seoul, South Korea
Site KR82004
Songpa-gu, Seoul, South Korea
Site ES34001
Barcelona, , Spain
Site ES34004
Madrid, , Spain
Site ES34002
Málaga, , Spain
Site ES34003
Seville, , Spain
Countries
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Central Contacts
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Other Identifiers
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jRCT2031220738
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20250465
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501590-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
3082-CL-0101
Identifier Type: -
Identifier Source: org_study_id
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