A Study of DS-1471a In Subjects With Advanced Solid Tumors

Last updated: April 16, 2025
Sponsor: Daiichi Sankyo Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

DS-1471a

Clinical Study ID

NCT06074705
DS1471-079
2024-517984-21-00
jRCT2031230234
  • Ages > 18
  • All Genders

Study Summary

This first-in-human (FIH) study will assess the safety, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

The clinical site will screen for the full inclusion criteria per protocol.

  • Sign and date the informed consent form (ICF)

  • Adults ≥18 years at the time the ICF is signed

  • Has a histologically or cytologically documented, locally advanced, metastatic, orunresectable solid tumor that is refractory to or intolerable with standardtreatment, or for which no standard treatment is available

  • Has at least 1 measurable lesion according to RECIST v1.1 1 on computed tomography (CT) or magnetic resonance imaging (MRI)

  • Is willing and able to provide tumor tissue (newly obtained or archived)

  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

  • Life expectancy ≥3 months

  • Has a left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to Cycle 1Day 1

  • Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) asprespecified in the protocol

  • A female participant of childbearing potential is eligible to participate if thefollowing conditions are met:

  • Not pregnant as confirmed by highly sensitive pregnancy test within 7 daysprior to study drug administration (Cycle 1 Day 1)

  • Agrees to adhere to a highly effective contraceptive method and agrees not todonate eggs or freeze/store eggs, during the intervention period, and for 7months following the last dose of study drug

  • A male participant is eligible to participate if he agrees to the following duringthe intervention period and for 4 months following the last dose of study drug:

  • Avoid donating sperm

  • Adhere to either abstinence or use of a condom during intercourse with anonparticipant of childbearing potential PLUS partner use of an additionalcontraceptive method

  • Is willing and able to comply with scheduled visits, study drug administration plan,laboratory tests, other study procedures, and study restrictions

  • Patients with liver cirrhosis and liver cancer may be eligible to participate ifthey meet additional protocol specified criteria

Exclusion

Key Exclusion Criteria:

The clinical site will screen for the full exclusion criteria per protocol.

  • Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day 1) as prespecified in the protocol

  • Has history of or current presence of untreated central nervous system (CNS)metastases

  • Has a history of leptomeningeal carcinomatosis

  • Has a history of (non-infectious) interstitial lung disease (ILD) other thanradiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled outby imaging at screening

  • Clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses

  • Has any of the following within the past 6 months: cerebrovascular accident,transient ischemic attack, arterial thromboembolic event, or pulmonary embolism

  • Has uncontrolled or clinically significant cardiovascular disease

  • Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)

  • Has multiple primary malignancies, except adequately resected non-melanoma skincancer, curatively treated in situ disease, superficial cancer in thegastrointestinal tract curatively resected by endoscopic surgery, or any other solidtumors curatively treated with no evidence of recurrent disease for ≥3 years

  • Has unresolved toxicities from previous anticancer treatment

  • Exposure to another investigational medical product within 4 weeks prior to Cycle 1Day 1 or current participation in other therapeutic investigational procedures

  • Has an active, known, or suspected autoimmune disease

  • Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.

  • Has an active hepatitis or uncontrolled hepatitis B or C infection, except forparticipants with hepatitis B infection that is controlled by antiviral therapy

  • For the Dose Escalation phase, has human immunodeficiency virus (HIV) infection. Forthe Dose Expansion phase, has active or uncontrolled HIV infection with exceptionsper protocol.

  • Has received a live, attenuated vaccine (messenger RNA [mRNA] andreplication-deficient adenoviral vaccines are not considered live, attenuatedvaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1)

  • Female who is pregnant or breastfeeding or intends to become pregnant during thestudy

  • Has psychological, social, familial, or geographical factors that would preventregular follow-up

  • Has prior or ongoing clinically relevant illness, medical condition, surgicalhistory, physical finding, or laboratory abnormality that, in the investigator'sopinion, could affect the safety of the subject; alter the absorption, distribution,metabolism, or excretion of the study drug; or confound the assessment of studyresults

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: DS-1471a
Phase: 1
Study Start date:
August 04, 2023
Estimated Completion Date:
June 01, 2027

Study Description

The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.

Connect with a study center

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • Florida Cancer Specialist

    Sarasota, Florida 34236
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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