A Study of DS-9606a in Patients With Advanced Solid Tumors

Last updated: March 25, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

1

Condition

Genitourinary Cancer

Vaginal Cancer

Brain Tumor

Treatment

DS-9606a

Clinical Study ID

NCT05394675
DS9606-137
2022-000120-38
REFMAL 823
  • Ages > 18
  • All Genders

Study Summary

This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old at the time of written informed consent

  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

  • Availability of archived tumor tissue samples (mandatory in Part A); patients withgerm cell tumors without archived tumor samples may be allowed with approval

  • Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either anechocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days beforethe start of study treatment

  • Adequate bone marrow and organ function within 7 days before the start of studytreatment

  • Life expectancy ≥3 months

  • Adequate treatment washout period prior to start of study treatment

  • Male patients with female partners of childbearing potential and female patients ofchild-bearing potential must agree to use a highly effective form of contraceptionor avoid intercourse during and upon completion of the study for at least 6 months (for males) and for at least 7 months (for females) after the last dose of studydrug. Males must agree not to freeze or donate sperm throughout the study period forat least 6 months after final administration of study drug. Investigators willadvise male patients on the conservation of sperm prior to study treatment. Femalesmust agree not to donate or retrieve ova for own use throughout the study period andfor at least 7 months after final study drug administration.

Dose Escalation Participants Only:

  • Histologically- or cytologically-documented locally advanced or metastatic cancers,including but not limited to: ovarian cancer (including fallopian tube and primaryperitoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreaticadenocarcinoma, non-squamous NSCLC, or gastric cancer

  • Disease progression with standard of care therapies for metastatic disease known toconfer benefit, or are intolerant to or refuse standard treatment.

Dose Expansion Participants Only:

  • Consent to tumor screening and to provide an archived tumor sample if available, ora newly obtained pre-treatment tumor biopsy and consent to provide pre-treatmentbiopsy sample and on-treatment tissue biopsy sample (mandatory if not clinicallycontraindicated)

  • Histologically or cytologically-documented locally advanced or metastatic ovariancancer

Exclusion

Exclusion Criteria:

  • Has history or current presence of central nervous system metastases, except forparticipants who have completed radiotherapy or surgery ≥4 weeks before the start oftreatment, and fulfill all criteria (no evidence of disease progression in the CNSand no requirement for chronic corticosteroids) within 2 weeks before the start oftreatment

  • Other invasive malignancy within 2 years; prior or concurrent non-invasivemalignancies and/or patients with localized malignancies that were treated withcurative intent who remain disease-free and are considered low likelihood forrecurrence may be enrolled

  • History of myocardial infarction or unstable angina within 6 months before studytreatment

  • Has a history of symptomatic congestive heart failure (New York Heart Associationclasses II-IV) or a serious cardiac arrhythmia requiring treatment

  • Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on theaverage of triplicate 12-lead electrocardiogram (ECG) per local read

  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired corticosteroids, current ILD/pneumonitis, or where suspectedILD/pneumonitis cannot be ruled out by imaging at screening.

  • Has an uncontrolled infection requiring ongoing or long-term therapy

  • Has a known active hepatitis or uncontrolled hepatitis B or C infection

Study Design

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: DS-9606a
Phase: 1
Study Start date:
May 31, 2022
Estimated Completion Date:
February 19, 2026

Study Description

This first-in-human, phase 1 study will consist of 2 parts. In Part A (Dose Escalation), the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE). In Part B (Dose Expansion), the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed.

The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a, and assess the immunogenicity of DS-9606a.

Connect with a study center

  • Sarah Cannon Research Institute UK

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Trust

    London, SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • SCRI at HealthONE

    Denver, Colorado 80216
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute, LLC

    Fort Myers, Florida 33916
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute, LLC

    Sarasota, Florida 33916
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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