A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors

NCT07094204 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 5834-CL-10012025-522082-29-00
• Study Type: interventional
• Target: 364
• Locations: 4 countries
• Sites: 19

Brief Summary

Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment. The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab. People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain. In this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab. This study will be in 2 parts: Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out from Part 1. In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. This is called an infusion. Each study treatment cycle is either 21 days or 28 days long. People will continue study treatment until: they have medical problems from the study treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop study treatment. People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people's cancer gets worse or the cancer comes back. People will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.

Conditions

Pancreatic Ductal Adenocarcinoma; Solid Tumor; Non-Small-Cell Lung Cancer; Colorectal Cancer

Keywords

Solid Tumor; Cancer; Malignancy; Metastasis; Pharmacokinetics; ASP5834; KRAS G12V; KRAS G12D; KRAS G12C; KRAS G12R; KRAS G12A; KRAS G13D; CRC; NSCLC; PDAC

Outcome Measures

Primary Outcomes (11)

• Incidence of Dose Limiting Toxicities (DLTs) (Dose Escalation only)

  A DLT is defined as any Adverse Event (AE) which meets DLT criteria, not clearly due to the underlying disease or extraneous causes, that occurs within the DLT observation period.

  Up to 21 days

• Number of participants with Adverse Events (AEs)

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.

  Up to 40 months

• Number of Participants with Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence that at any dose either 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 or other medical situation.

  Up to 40 months

• Number of participants with laboratory value abnormalities and/or adverse events (AEs)

  Number of participants with potentially clinically significant laboratory values.

  Up to 40 months

• Number of Participants with Eye Exam abnormalities and/or Adverse Events (AEs)

  Number of participants with potentially clinically significant eye exam values.

  Up to 39 months

• Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)

  Number of participants with potentially clinically significant ECG values.

  Up to 39 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 40 months

• Number of participants with echocardiogram (ECHO) abnormalities and/or adverse events (AEs)

  Number of participants with potentially clinically significant ECHO values.

  Up to 39 months

• Number of participants with multigated acquisition (MUGA) abnormalities and/or adverse events (AEs)

  Number of participants with potentially clinically significant MUGA values.

  Up to 39 months

• Number of Participants with Physical Examination (PE) abnormalities and/or AEs

  Number of participants with potentially clinically significant PE values.

  Up to 40 months

• Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

  The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores represent an improvement. Positive scores represent a decline in performance.

  Up to 40 months

Secondary Outcomes (13)

• Objective Response Rate (ORR) of ASP5834 per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to 45 months

• Duration of Response (DOR) of ASP5834 per RECIST v1.1

  Up to 45 months

• Disease Control Rate (DCR) of ASP5834 per RECIST v1.1

  Up to 45 months

• Progression Free Survival (PFS) per RECIST v1.1

  Up to 45 months

• Overall Survival (OS)

  Up to 45 months

Study Arms (6)

ASP5834 Dose Escalation

EXPERIMENTAL

Participants will receive sequential doses levels of ASP5834 intravenously following 1 of 2 dose regimens.

Drug: ASP5834

ASP5834 Dose Expansion (Tumor/ Mutation Specific)

EXPERIMENTAL

Participants with select tumor types will receive 1 of 2 dose regimens of ASP5834 with dose level(s) selected from dose escalation.

Drug: ASP5834

ASP5834 Dose Expansion (Dose-ranging)

EXPERIMENTAL

Participants will receive dose level(s) and regimen of ASP5834 based on emerging data from Dose Escalation alone or Dose Escalation and Dose Expansion cohorts.

Drug: ASP5834

ASP5834 combination therapy Dose Escalation

EXPERIMENTAL

Participants will receive sequential doses levels of ASP5834 intravenously following 1 of 2 dose regimens based on emerging data. Panitumumab will be administered every 2 weeks.

Drug: ASP5834; Drug: panitumumab

ASP5834 monotherapy therapy Dose Expansion

EXPERIMENTAL

Participants will receive 1 of 2 dose regimens of ASP5834.

Drug: ASP5834

ASP5834 combination therapy Dose Expansion

EXPERIMENTAL

Participants will receive ASP5834 and panitumumab with dose level(s) and regimen selected from dose escalation (Combination Therapy). Panitumumab will be administered every 2 weeks.

Drug: ASP5834; Drug: panitumumab

Interventions

panitumumab DRUG

Intravenous infusion

ASP5834 combination therapy Dose Escalation; ASP5834 combination therapy Dose Expansion

ASP5834 DRUG

Intravenous infusion

ASP5834 Dose Escalation; ASP5834 Dose Expansion (Dose-ranging); ASP5834 Dose Expansion (Tumor/ Mutation Specific); ASP5834 combination therapy Dose Escalation; ASP5834 combination therapy Dose Expansion; ASP5834 monotherapy therapy Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number \>/= 4) determined by local testing.
• For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation are eligible.
• Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.
• For the ASP5834 monotherapy dose escalation part, participant with any histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy is eligible. Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or the participant is ineligible to receive standard approved therapies.
• For the ASP5834 monotherapy dose expansion part, the following criteria apply:
• \[pancreatic ductal adenocarcinoma (PDAC) Expansion Cohort(s)\] Participant has histologically confirmed locally advanced (unresectable) or metastatic PDAC.
• \[PDAC Expansion Cohort(s)\] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.
• \[PDAC Expansion Cohort(s)\] Participant must have received standard therapy in the advanced setting, including prior therapy with a gemcitabine-based or fluoropyrimidine-based regimen or is ineligible for these therapies.
• \[PDAC Expansion Cohort(s)\] No more than 2 prior lines of systemic therapy are allowed in the advanced setting (note: maintenance therapy does not count as a separate line of therapy).
• \[PDAC Expansion Cohort(s)\] For a participant who received prior neoadjuvant or adjuvant chemotherapy and had recurrence on or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be counted as a regimen in the advanced setting.
• \[non-small cell lung cancer (NSCLC) Expansion Cohort(s)\] Participant has histologically confirmed locally advanced (unresectable) or metastatic NSCLC.
• \[NSCLC Expansion Cohort(s)\] Participant has a documented KRAS G12V, G12D, G12R, G12A or G13D mutation determined by local testing.
• \[NSCLC Expansion Cohort(s)\] Participant must have received standard therapy in the advanced setting, including prior platinum-based chemotherapy and checkpoint inhibitor therapy or is ineligible for these therapies. Participants with known actionable genomic alterations (AGA) must have received prior therapy with an approved targeted therapy in accordance with local requirements.
• \[NSCLC Expansion Cohort(s)\] For a participant who has received prior neoadjuvant or adjuvant therapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy should be counted as a regimen in the advanced setting (for those who received perioperative therapy, the entire course should be counted as therapy in the advanced setting).
• \[NSCLC Expansion Cohort(s)\] For a participant with a history of unresectable Stage III disease who received prior multi-modal therapy and had recurrence on or within 6 months of completion of therapy, the multi-modal therapy should be counted as a therapy in the advanced setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy without documented progression between chemoradiation and checkpoint inhibitor therapy, the entire treatment course should be counted as therapy in the advanced setting.

You may not qualify if:

• Participant has adequate organ function as indicated by laboratory values (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 has a negative urine or serum pregnancy test within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final investigational study intervention administration.
• Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 6 months after final investigational study intervention administration.
• Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final investigational study intervention administration.
• Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final investigational study intervention administration.
• Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final investigational study intervention administration.
• Male participant must not donate sperm during the treatment period and for 3 months after final investigational study intervention administration.
• Participant agrees not to participate in another interventional study while receiving study intervention in the present study/participating in the present study.
• Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with stable, asymptomatic and treated CNS metastases are eligible.
• Participant has leptomeningeal disease as a manifestation of the current malignancy.
• Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, 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 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 with Acquired Immune Deficiency Syndrome (AIDS) related complications. No HIV testing is required unless mandated by a local health authority.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (19)

UCLA Santa Monica Hematology Oncology

Santa Monica, California, 90404, United States

RECRUITING

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Ochsner Health

Jefferson, Louisiana, 70121, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University Hospitals - UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

NEXT Oncology Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Site FR33003

Bordeaux, Nouvelle-Aquitaine, France

RECRUITING

Site FR33002

Lyon, France

RECRUITING

Site FR33004

Pierre-Bénite, France

RECRUITING

Site FR33001

Villejuif, France

RECRUITING

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

RECRUITING

Site ES34005

Barcelona, Catalonia, Spain

RECRUITING

Site ES34001

Madrid, Spain

RECRUITING

Site ES34003

Madrid, Spain

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Lead

  Astellas Pharma Inc

  STUDY DIRECTOR

Central Study Contacts

Astellas Pharma Global Development, Inc.

CONTACT

800-888-7704; Astellas.registration@astellas.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

FR (4); ES (3); US (11); JP (1)