A Study of ASP3082 in Adults With Advanced Solid Tumors

A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Cetuximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Pembrolizumab; Drug: Leucovorin; Drug: Fluorouracil; Drug: Irinotecan; Drug: Nanoparticle albumin-bound-paclitaxel; Drug: Docetaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Setidegrasib; Drug: Liposomal Irinotecan

• Study Type: Interventional
• Enrollment (Estimated): 681
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Astellas Pharma Global Development, Inc.; Phone Number: 800-888-7704; Email: Astellas.registration@astellas.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Cancer Hospital
  • Shanghai Municipality
    • Xuhui District, Shanghai Municipality, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
• France
  • Bordeaux, France
    • Recruiting
    • Site FR33002
  • Lyon, France
    • Recruiting
    • Site FR33001
  • Lyon, France
    • Recruiting
    • Site FR33005
  • Grenobele
    • La Tronche, Grenobele, France
      • Recruiting
      • Site FR33003
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France
      • Recruiting
      • Site FR33004
• Japan
  • Osaka, Japan
    • Recruiting
    • Osaka International Cancer Institute
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan
      • Recruiting
      • Aichi Cancer Center
  • Chiba
    • Kashiwa, Chiba, Japan
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan
      • Recruiting
      • Shikoku Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Recruiting
      • Hokkaido University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • Recruiting
      • Kanagawa Cancer Center
  • Miyagi
    • Sendai, Miyagi, Japan
      • Recruiting
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan
      • Recruiting
      • Niigata Cancer Center Hospital
  • Osaka
    • Sayama, Osaka, Japan
      • Recruiting
      • Kindai University Hospital
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan
      • Recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan
      • Recruiting
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan
      • Recruiting
      • Cancer Institute Hospital of JFCR
  • Yamaguchi
    • Ube, Yamaguchi, Japan
      • Recruiting
      • Yamaguchi University Hospital
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Recruiting
    • PanOncology Trials
• South Korea
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea
      • Recruiting
      • Site KR82005
    • Seongnam-si, Gyeonggi-do, South Korea
      • Recruiting
      • Site KR82002
  • Seoul
    • Jongno -Gu, Seoul, South Korea
      • Recruiting
      • Site KR82001
    • Seodaemun-gu, Seoul, South Korea
      • Recruiting
      • Site KR82003
    • Songpa-gu, Seoul, South Korea
      • Recruiting
      • Site KR82004
• Spain
  • Barcelona, Spain
    • Recruiting
    • Site ES34001
  • Madrid, Spain
    • Recruiting
    • Site ES34004
  • Málaga, Spain
    • Recruiting
    • Site ES34002
  • Seville, Spain
    • Recruiting
    • Site ES34003
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope National Medical Center
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA Santa Monica Hematology Oncology
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Denver HealthONE Drug Development Unit
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Smilow Cancer Center at Yale New Haven Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida, Davis Cancer Center
    • Lake Mary, Florida, United States, 32746
      • Recruiting
      • Florida Cancer Specialist
    • Sarasota, Florida, United States, 34232-6422
      • Recruiting
      • Florida Cancer Specialists & Research Institute Sarasota
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • Trinity Health Ann Arbor Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University - Herbert Irving Comprehensive Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Terminated
      • SCRI Oncology Partners
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology - Virginia Cancer Specialists
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University Of Wisconsin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation and 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).
• For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study
• For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: 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 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 (or prior to staring SoC chemotherapy, for first line (1L) participants receiving Nab-P+GEM FOLFIRINOX or NALIRIFOX.
• 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.
  • EU only: For combination therapy with carboplatin, follow contraception guidelines from the time of informed consent through at least 7 months after the final dose of carboplatin.
  • South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 15 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 14 months after the final dose of cisplatin.
• 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.
• South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 12 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 11 months after the final dose of cisplatin.
• 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 received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP3082 Dose Escalation (Monotherapy Part 1); Participants will receive ASP3082 in a 21-day cycle.	Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: 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.	Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1); Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.	Drug: Cetuximab; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: ASP3082 China Safety Cohort; Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.	Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: 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.	Drug: Cetuximab; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: 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.	Drug: Oxaliplatin; Intravenous Infusion; Drug: Leucovorin; Intravenous Infusion; Drug: Fluorouracil; Intravenous Infusion; Drug: Irinotecan; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: 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.	Drug: Gemcitabine; Intravenous Infusion; Drug: Nanoparticle albumin-bound-paclitaxel; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: ASP3082 + Docetaxel - NSCLC; Participants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.	Drug: Docetaxel; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: ASP3082 + Pembrolizumab - NSCLC; Participants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.	Drug: Pembrolizumab; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: 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.	Drug: Pembrolizumab; Intravenous Infusion; Drug: Cisplatin; Intravenous Infusion; Drug: Carboplatin; Intravenous Infusion; Drug: Pemetrexed; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082
Experimental: Treatment naive PDAC cohort ASP3082 + NALIRIFOX; Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with NALIRIFOX (leucovorin[LV]/fluorouracil[5-FU]/liposomal irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.	Drug: Oxaliplatin; Intravenous Infusion; Drug: Leucovorin; Intravenous Infusion; Drug: Fluorouracil; Intravenous Infusion; Drug: Setidegrasib; Intravenous Infusion; Other Names: ASP3082; Drug: Liposomal Irinotecan; Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study IP, whether or not considered related to the study investigational product (IP). Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.	Up to 48 months
Number of Participants with laboratory value abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant laboratory values.	Up to 48 months
Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant ECG values.	Up to 48 months
Number of Participants with vital sign abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant vital sign values.	Up to 48 months
Number of Participants with physical exam abnormalities and/or adverse events	Number of participants with potentially clinically significant physical exam values.	Up to 48 months
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status	The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.	Up to 48 months
Incidence of Dose Limiting Toxicities (DLTs)	A DLT is defined as any event meeting the DLT criteria excluding toxicities clearly related to disease progression or intercurrent illness or standard of care (SoC) regimens as determined by the investigator.	Up to 28 Days
Number of Participants with Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.	Up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1.	Up to 48 months
Duration of Response (DOR) per RECIST v 1.1	DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date of documented radiological disease progression per RECIST v1.1 or death in the absence of progression.	Up to 48 months
Disease Control Rate (DCR) per RECIST v 1.1	DCR is defined as the proportion of participants whose best overall response is rated as CR, PR or SD based on RECIST v1.1.	Up to 48 months
Pharmacokinetics (PK) of ASP3082 in plasma: Area under the concentration-time curve (AUC)	AUC will be recorded from the PK plasma samples collected.	Up to 48 months
PK of ASP3082 in plasma: Maximum Concentration (Cmax)	Cmax will be recorded from the PK plasma samples collected.	Up to 48 months
PK of ASP3082 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)	Ctrough will be recorded from the PK plasma samples collected.	Up to 48 months
PK of ASP3082 in plasma: Time of maximum concentration (tmax)	tmax will be recorded from the PK plasma samples collected.	Up to 48 months
Changes in Kirsten rat sarcoma (KRAS) viral oncogene homolog G12D in tumor samples	Changes in KRAS G12D in tumor samples will be measured.	Up to 48 months

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

General Publications

• Park W, Kasi A, Spira AI, Paz-Ares Rodriguez L, Herzberg BO, Pelster MS, Tolcher AW, Kuboki Y, Kitano S, Shoji H, Wang JS, Berlin JD, Hollebecque A, LoRusso P, Fountzilas C, Cassier PA, Nishina T, Sakai D, Inagaki C, Morgensztern D, Ueno M, Jung M, Kim SW, Janne PA, Italiano A, You B, Macarulla T, Fujii H, Shetty A, Lu Y, Cui D, Kadam S, Gill SC, Toyoshima J, Saito T, Goldman JW. Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer. N Engl J Med. 2026 Mar 25. doi: 10.1056/NEJMoa2600752. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; NSCLC; Pharmacokinetics; Solid Tumor; Malignancy; CRC; PDAC; Metastasis; ASP3082; KRAS G12D; setidegrasib
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Neoplasm Metastasis; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Care Economics and Organizations; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Platinum Compounds; Economics; Docetaxel; Oxaliplatin; Irinotecan; Pemetrexed; Cetuximab; Gemcitabine; Fluorouracil; Carboplatin; Leucovorin; Cisplatin; pembrolizumab; irinotecan sucrosofate; Taxes
• Other Study ID Numbers: 3082-CL-0101; jRCT2031220738 (Registry Identifier: jRCT); CTR20250465 (Registry Identifier: chinaDrugTrials.org.cn); 2022-501590-39-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No