A Study of ASP2074 in Adults With Solid Tumors

NCT05646797 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 2074-CL-0101jRCT2031220554
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 13

Brief Summary

ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and check for potential medical problems from the treatment. People in this study will be adults with metastatic or locally advanced solid tumors. Metastatic means the cancer has spread to other parts of the body. They will have been previously treated with all available standard therapies and they may no longer be benefitting from further treatment. There are 2 main aims of this study. The first is to learn if people with certain solid tumors have any medical problems after receiving different doses of ASP2074. The second is to find a suitable dose of ASP2074 to use in future studies. This study will be in 2 parts. In Part 1, different small groups of people will receive lower or higher doses of ASP2074. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2074 to use in Part 2 of the study. The first group will receive the lowest dose of ASP2074. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2074. The panel will do this for each group until all groups have taken ASP2074 or until suitable doses have been selected for Part 2. In Part 2, other different small groups of people will receive ASP2074 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP2074 to use in future studies. ASP2074 will be given as an infusion on the first day of each treatment cycle. The people in this study will have treatment cycles until: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. During these visits, the study doctors will check for any medical problems from ASP2074. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood and urine samples will be taken. Electrocardiograms will be done to check the heart rhythm during the study. Tumor samples will be taken during certain visits before treatment begins, during treatment, and when treatment has finished. People will visit the clinic within 7 days after stopping treatment. The study doctors will check for any medical problems from ASP2074. Other checks will include a medical examination, laboratory tests and vital signs. Then, people may visit the clinic at 30 days after stopping treatment. Thirty and 90 days after the last dose, the study doctors will check for any medical problems from ASP2074. People will have their vital signs checked and have some laboratory tests. After this, people will continue to visit the clinic every 6 weeks. This is to check the condition of their cancer. They will do this until their cancer is worse, they start other cancer treatment, they ask to leave the study, or they do not come back for treatment. Then, the study doctors will call every 12 weeks for up to 1 year or until that person asks to leave the study, the study is stopped, or the person cannot be reached.

Conditions

Advanced Solid Tumors

Keywords

Solid Tumor;; Malignancy;; Metastasis;; cancer;; ASP2074;; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Incidence of Dose Limiting Toxicities (DLTs) for ASP2074

  A Dose Limiting Toxicity (DLT) is defined as any prespecified Adverse events (AEs) or laboratory findings occurring during the DLT evaluation period excluding toxicities clearly related to disease progression or intercurrent illness.

  Up to up to 28 Days

• Number of participants with Adverse Events (AEs)

  Adverse events (AEs) will be coded using MedDRA. An 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.

  Up to 15 Months

• Number of participants with Serious Adverse Events (SAEs)

  A Serious Adverse event (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, or other medically important event.

  Up to 15 Months

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

  Number of participants with potentially clinically significant laboratory values.

  Up to 13 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 15 Months

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

  Number of participants with potentially clinically significant ECG values.

  Up to 15 Months

Secondary Outcomes (13)

• Objective Response Rate (ORR) per Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)

  Up to 21 Months

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

  Up to 21 Months

• Duration of Response (DOR) per iRECIST

  Up to 21 Months

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

  Up to 21 Months

• Disease Control Rate (DCR) per iRECIST

  Up to 21 Months

Study Arms (4)

ASP2074 Dose Escalation (Part 1)

EXPERIMENTAL

Participants will be assigned to sequentially or in parallel escalating dose/regimen cohorts of ASP2074 in three parts (Part A, B and C). Part B and Part C will be opened sequentially based upon sponsor review of emerging data.

Drug: ASP2074

ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma

EXPERIMENTAL

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP2074

ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma

EXPERIMENTAL

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP2074

ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma

EXPERIMENTAL

Participants will receive ASP2074 with dose/regimen selected from dose escalation (Part 1).

Drug: ASP2074

Interventions

ASP2074 DRUG

intravenous (IV) infusion

ASP2074 Dose Escalation (Part 1); ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma; ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma; ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma

Eligibility Criteria

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

You may qualify if:

• Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) which is confirmed by available pathology records or current biopsy. For dose escalation, the participant must have colorectal, pancreatic, gastric cancer, esophageal or Gastroesophageal junction (GEJ) adenocarcinoma. For the tumor-specific expansion cohorts, the participant must have colorectal adenocarcinoma, esophageal or GEJ adenocarcinoma, or pancreatic adenocarcinoma.
• Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Participant has progressed or failed to tolerate after receiving all standard approved therapies or is no longer eligible for standard therapy (no limit to the number of prior treatment regimens).
• Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.
• Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to study intervention administration.
• Participant's adverse events (excluding alopecia) from prior therapy have improved to grade 1 or baseline for the participant (e.g., grade 2 hypothyroidism) within 14 days prior to the first dose of study intervention.
• Participant has predicted life expectancy \>/= 12 weeks.
• Participant must meet all of the criteria based on laboratory tests. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>/= 2 weeks after any blood transfusion.
• Female participant is not pregnant confirmed by serum 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 90 days after final study intervention administration.
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 90 days after final study intervention administration.
• Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 90 days after final 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 90 days after final study intervention administration.
• Male participant must not donate sperm during the treatment period and for 90 days after final study intervention administration.

You may not qualify if:

• Participant has received other investigational agents or devices concurrently or within 21 days or 5 half-lives, whichever is shorter, prior to first dose of study intervention administration.
• Participant has any condition which makes the participant unsuitable for study participation.
• Participant has a known or suspected hypersensitivity to ASP2074 or any components of the formulation used.
• Participants with squamous cell colorectal carcinoma; gastrointestinal stromal tumor and neuroendocrine carcinomas.
• Participant weighs \< 40 kg.
• Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study intervention administration. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day prednisone), receiving a single dose of systemic corticosteroids, or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is eligible.
• Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of central nervous system (CNS) progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (\> 30 mg per day of hydrocortisone or \> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
• Participant has an active autoimmune disease. Participants with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
• Participant was discontinued from prior immunomodulatory therapy due to a grade \>/= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
• Participant is known to have HIV infection. However, participants with HIV infection with CD4+ T-cell counts ≥ 350 cells/μL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for human immunodeficiency virus (HIV) infection should be conducted per local requirements.
• Participant is known to have active hepatitis B (positive hepatitis B surface antigen (HBsAg)) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.
• For participant who is negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B virus (HBV) DNA test will be performed and if positive the participant will be excluded.
• Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.
• Participant treated for HCV with undetectable viral load results are eligible
• Participant has received a live vaccine against infectious diseases within 28 days prior to initiation of study treatment.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (13)

University of California Davis Health System

Sacramento, California, 95817, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Next Oncology - Oncology

San Antonio, Texas, 78229, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Location

Osaka International Cancer Institute

Osaka, Japan

Location

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website.
• Link to results and other applicable study documents on the Astellas Clinical Trials website.

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

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: December 1, 2022
• First Posted: December 12, 2022
• Study Start: February 28, 2023
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); JP (5)