Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

This study is one single group of participants with NSCLC who have not been cured by other treatments. It is the first time the drug has been used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a This study is expected to last approximately 2.5 years from the time the first subject is enrolled to the time the last subject is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.

Official Title

Phase 1, Two-part, Multicenter, Non-randomized, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors

Details

The dosage strength will change during the study but all participants will receive the same study drug. So the study is not a true 2-arm study, it is a 2-part study.

In both parts, subjects with pathologically documented unresectable advanced NSCLC who have been refractory to or relapsed from standard treatment or for which no standard treatment is available, will be enrolled. Additional solid tumors might be evaluated, if the study treatment demonstrates acceptable safety, tolerability and efficacy in NSCLC patients. After the primary analysis, the main (registered) study will be considered complete, but data will be collected from participants who continue receiving study drug.

Keywords

Carcinoma, Non-Small-Cell Lung Non-small cell lung cancer NSCLC Other solid tumors DS-1062a

Eligibility

You can join if…

Open to people ages 18 years and up

  • Has a pathologically documented unresectable advanced NSCLC disease not amenable to curative therapy
  • Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
  • Consents to provide tumor tissue sample for the measurement of recent TROP2 levels by immunohistochemistry, which means archived sample following last treatment or pre-DS1062a treatment biopsy (there is no minimum TROP2 expression level required for inclusion)
  • Is aged ≥20 years old in Japan or ≥18 years old in other countries
  • Has an Eastern Cooperative Oncology Group performance status 0-1
  • Has a left ventricular ejection fraction (LVEF) ≥50% by either an ECHO or MUGA within 28 days before registration
  • Has measurable disease based on RECIST version1.1
  • Has adequate organ function within 7 days before enrollment
  • Has an adequate treatment washout period prior to enrollment
  • If of reproductive potential, agrees to use a highly effective from of contraception or avoid intercourse during and upon completion of the study and for at least 4 months after the last dose of study drug, and agrees not to retrieve, freeze or donate sperm or ova starting at Screening and throughout the study period, and at least 4 months after the final study drug administration
  • After being fully informed about their illness and the investigative nature of the protocol (including foreseeable risks and possible toxicities), is willing and able comply with the protocol and to provide written, ethics committee-approved informed consent form before performance of any study-specific procedures or examinations
  • Has a life expectancy of ≥3 months
  • If the study Sponsor decides to evaluate additional solid tumors, subjects must satisfy following criteria to be included in the study: Has a pathologically documented advanced solid tumor.

You CAN'T join if...

  • Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated,with no evidence of disease for ≥3 years
  • Has a history of myocardial infarction or unstable angina within 6 months before enrollment
  • Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment Has a corrected QT by Fridericia's formula (QTcF), of >470 ms based on a triplicate 12-lead ECG
  • Has clinically significant lung disease or is suspected to have such diseases by imaging at Screening
  • Has clinically significant corneal disease
  • Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Has active human immunodeficiency virus infection that is uncontrolled (increasing plasma HIV RNA viral load) with medication, or has an active hepatitis B or C infection
  • Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms(participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy)
  • Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment
  • Has unresolved toxicities from previous anticancer therapy
  • Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator
  • Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product
  • Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Virginia Cancer Specialists accepting new patients
    Fairfax Virginia 22031 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo Co., Ltd.
ID
NCT03401385
Phase
Phase 1
Study Type
Interventional
Last Updated