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



This study is one single group of participants with non-small cell lung cancer (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 4 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. 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, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors


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, participants 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 and/or triple negative breast cancer (TNBC) participants. After the primary analysis, the main (registered) study will be considered complete, but data will be collected from participants who continue receiving study drug.


Carcinoma, Non-Small-Cell Lung Triple Negative Breast Cancer Non-small cell lung cancer NSCLC Other solid tumors TNBC Triple Negative Breast Neoplasms


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 (NSCLC participants only).
  • Has a pathologically documented advanced/unresectable or metastatic triple negative breast cancer (TNBC participants only).
  • Has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
  • Consents to provide mandatory pre-treatment tumor tissue samples for the measurement of TROP2 and other biomarkers. There is no minimum TROP2 expression level required for inclusion.
  • Consents to undergo mandatory on-treatment biopsy if clinically feasible and not contraindicated at the time of on-treatment biopsy, and consents to provide the tumor tissue samples from on-treatment biopsy for the measurement of TROP2 level and other biomarkers.
  • 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 enrollment.
  • Has measurable disease based on RECIST version1.1.
  • Has adequate bone marrow reserve and organ function within 7 days before Cycle 1, Day
  • Has an adequate treatment washout period prior to Cycle 1, Day 1.
  • If of reproductive/childbearing potential, agrees to use a highly effective from of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males 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 7 months for males and 4 months for males 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, participants 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 mean corrected QT interval (QTcF) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate 12-lead ECGs.
  • Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out 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 spinal cord compression or clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment. 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 a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients.
  • Has substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement, or prior pneumonectomy.


  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Next Oncology accepting new patients
    San Antonio Texas 78229 United States
  • START Oncology accepting new patients
    San Antonio Texas 78229 United States


accepting new patients
Start Date
Completion Date
Daiichi Sankyo Co., Ltd.
Phase 1
Study Type
Last Updated