AzTrials
AzTrials

Solid TumorPhase 1NCT05382559

A Study of ASP3082 in Adults With Advanced Solid Tumors

A Phase 1 study testing Setidegrasib, Cetuximab and Leucovorin in people with Solid Tumor, run by Astellas Pharma Inc at 68 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Setidegrasib, Cetuximab and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
681 participants
Where
68 sitesin 7 countries
Study dates
8 Jun 2022to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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).
  • For ASP3082 Combination Therapy with Pembrolizumab (Cohort G), or Platinum-based Chemotherapy + Pemetrexed +/- Pembrolizumab (Cohort H): Participant must have pathologically documented locally advanced or metastatic (unresectable Stage IIIB-IV) non-small cell lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and
  • have received prior platinum-containing chemotherapy (safety lead-in only) or
  • have never received systemic therapy (up to 1 cycle of SoC pembrolizumab [defined as one 21-day cycle of 200 mg] in Cohort G and up to 1 cycle of SoC platinum-based chemotherapy ± pembrolizumab [defined as one 21-day cycle of 200 mg] or pembrolizumab [defined as one 21-day cycle of 200 mg] in Cohort H is permitted prior to Screening, provided a 21-day washout occurs before C1D1) for locally advanced or metastatic NSCLC with no oncogenic driver mutations. Participants who received adjuvant or neoadjuvant platinum-based chemotherapy and developed recurrent or metastatic disease more than 12 months after completing therapy may be enrolled.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

68 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Astellas Pharma Global Development, Inc. contact

800-888-7704

astellas.registration@astellas.com

68 sites in 7 countries

United States26 sites, 23 recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Recruiting

  • Case Western

    Cleveland, Ohio, 44106

    Recruiting

  • Denver HealthONE Drug Development Unit

    Denver, Colorado, 80218

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Recruiting

  • NEXT Oncology - Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • University of Florida, Davis Cancer Center

    Gainesville, Florida, 32610

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Florida Cancer Specialist

    Lake Mary, Florida, 32746

    Terminated

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Terminated

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Smilow Cancer Center at Yale New Haven Hospital

    New Haven, Connecticut, 06520-8028

    Recruiting

  • Columbia University - Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

    Terminated

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • University of Rochester Medical Center James P. Wilmot Cancer Center

    Rochester, New York, 14642

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Recruiting

  • UCLA Santa Monica Hematology Oncology

    Santa Monica, California, 90404

    Recruiting

  • Florida Cancer Specialists & Research Institute Sarasota

    Sarasota, Florida, 34232-6422

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Recruiting

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

    Recruiting

  • Trinity Health Ann Arbor Hospital

    Ypsilanti, Michigan, 48197

    Recruiting

Other trials in United States

Japan15 sites, 14 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

    Terminated

  • Kansai Medical University Hospital

    Hirakata, Osaka

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba

    Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo

    Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka

    Recruiting

  • Shikoku Cancer Center

    Matsuyama, Ehime

    Recruiting

  • Aichi Cancer Center

    Nagoya, Aichi-ken

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata, Niigata

    Recruiting

  • Osaka International Cancer Institute

    Osaka

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido

    Recruiting

  • Kindai University Hospital

    Sayama, Osaka

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi

    Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa

    Recruiting

Other trials in Japan

Spain11 sites, 11 recruiting

  • Site ES34009

    A Coruña

    Recruiting

  • Site ES34001

    Barcelona

    Recruiting

  • Site ES34005

    Barcelona

    Recruiting

  • Site ES34008

    Barcelona

    Recruiting

  • Site ES34004

    Madrid

    Recruiting

  • Site ES34006

    Madrid

    Recruiting

  • Site ES34007

    Madrid

    Recruiting

  • Site ES34002

    Málaga

    Recruiting

  • Site ES34011

    Pamplona, Navarre

    Recruiting

  • Site ES34003

    Seville

    Recruiting

  • Site ES34010

    Valencia

    Recruiting

Other trials in Spain

South Korea7 sites, 7 recruiting

  • Site KR82007

    Cheongju-si, North Chungcheong

    Recruiting

  • Site KR82005

    Goyang-si, Gyeonggi-do

    Recruiting

  • Site KR82001

    Jongno -Gu, Seoul

    Recruiting

  • Site KR82003

    Seodaemun-gu, Seoul

    Recruiting

  • Site KR82002

    Seongnam-si, Gyeonggi-do

    Recruiting

  • Site KR82006

    Seoul

    Recruiting

  • Site KR82004

    Songpa-gu, Seoul

    Recruiting

Other trials in South Korea

France5 sites, 5 recruiting

  • Site FR33002

    Bordeaux

    Recruiting

  • Site FR33003

    La Tronche, Grenobele

    Recruiting

  • Site FR33001

    Lyon

    Recruiting

  • Site FR33005

    Lyon

    Recruiting

  • Site FR33004

    Villejuif, Île-de-France Region

    Recruiting

Other trials in France

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai

    Recruiting

  • Fudan University Shanghai Cancer Center

    Xuhui District, Shanghai Municipality

    Recruiting

Other trials in China

Puerto Rico1 site, 1 recruiting

  • PanOncology Trials

    San Juan, 00935

    Recruiting

Other trials in Puerto Rico

About this study

Official title: 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.

Read more

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
Solid Tumor
Being tested
Setidegrasib, Cetuximab, Leucovorin, Oxaliplatin, Fluorouracil
Keywords
Solid Tumor, Cancer, Malignancy, Metastasis, Pharmacokinetics, setidegrasib, ASP3082, KRAS G12D, NSCLC, CRC, PDAC
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05382559
Study groupRoleWhat they receive
ASP3082 Dose Escalation (Monotherapy Part 1)ExperimentalParticipants will receive ASP3082 in a 21-day cycle.
Receives: Drug: Setidegrasib
ASP3082 Dose Expansion (Monotherapy Part 2)ExperimentalParticipants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
Receives: Drug: Setidegrasib
ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)ExperimentalParticipants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.
Receives: Drug: Setidegrasib; Drug: Cetuximab
ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)ExperimentalParticipants 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.
Receives: Drug: Setidegrasib; Drug: Cetuximab
ASP3082 China Safety CohortExperimentalParticipants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.
Receives: Drug: Setidegrasib
Treatment naive PDAC cohort ASP3082 + FOLFIRINOXExperimentalUpon 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.
Receives: Drug: Setidegrasib; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Irinotecan
Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + GemcitabineExperimentalUpon 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.
Receives: Drug: Setidegrasib; Drug: Nanoparticle albumin-bound-paclitaxel; Drug: Gemcitabine
ASP3082 + Docetaxel - NSCLCExperimentalParticipants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.
Receives: Drug: Setidegrasib; Drug: Docetaxel
ASP3082 + Pembrolizumab - NSCLCExperimentalParticipants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.
Receives: Drug: Setidegrasib; Drug: Pembrolizumab
ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLCExperimentalParticipants 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.
Receives: Drug: Setidegrasib; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Treatment naive PDAC cohort ASP3082 + NALIRIFOXExperimentalUpon 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.
Receives: Drug: Setidegrasib; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Liposomal Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 Days

  2. 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.

    Measured: Up to 48 months

  3. 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.

    Measured: Up to 48 months

  4. Number of Participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 48 months

  5. Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant ECG values.

    Measured: Up to 48 months

  6. Number of Participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 48 months

  7. Number of Participants with physical exam abnormalities and/or adverse events

    Number of participants with potentially clinically significant physical exam values.

    Measured: Up to 48 months

  8. 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.

    Measured: Up to 48 months

Secondary outcomes (8)

  1. 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.

    Measured: Up to 48 months

  2. 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.

    Measured: Up to 48 months

  3. 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.

    Measured: Up to 48 months

  4. Pharmacokinetics (PK) of ASP3082 in plasma: Area under the concentration-time curve (AUC)

    AUC will be recorded from the PK plasma samples collected.

    Measured: Up to 48 months

  5. PK of ASP3082 in plasma: Maximum Concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 48 months

  6. PK of ASP3082 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)

    Ctrough will be recorded from the PK plasma samples collected.

    Measured: Up to 48 months

  7. PK of ASP3082 in plasma: Time of maximum concentration (tmax)

    tmax will be recorded from the PK plasma samples collected.

    Measured: Up to 48 months

  8. Changes in Kirsten rat sarcoma (KRAS) viral oncogene homolog G12D in tumor samples

    Changes in KRAS G12D in tumor samples will be measured.

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start8 Jun 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
681 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382559
Sponsor's protocol ID
3082-CL-0101
Other IDs
jRCT2031220738, CTR20250465, 2022-501590-39-00
Status last verified
Oct 2026
First submitted
16 May 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/.

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 Apr 9;394(14):1409-1420. doi: 10.1056/NEJMoa2600752. Epub 2026 Mar 25.

    PubMed 41879829

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Setidegrasib, Cetuximab and Leucovorin in people with Solid Tumor, run by Astellas Pharma Inc at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Japan, Spain, South Korea, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Astellas Pharma Global Development, Inc. (800-888-7704, astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLTs) (time frame: Up to 28 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382559, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in