Phase
Condition
Genitourinary Cancer
Vaginal Cancer
Brain Tumor
Treatment
DS-9606a
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Sarah Cannon Research Institute UK
London, W1G 6AD
United KingdomActive - Recruiting
The Royal Marsden NHS Trust
London, SM2 5PT
United KingdomActive - Recruiting
The Royal Marsden NHS Trust
Sutton, SM2 5PT
United KingdomActive - Recruiting
SCRI at HealthONE
Denver, Colorado 80216
United StatesActive - Recruiting
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida 33916
United StatesActive - Recruiting
Florida Cancer Specialists & Research Institute, LLC
Sarasota, Florida 33916
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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