Locally advanced or metastatic solid tumors
Conditions
Interventions
Generic name etc : DS-1471a
Dosage and Administration for Investigational material : Dose Escalation Part : IV solution (Once every 4 weeks, initial dose 1 mg /kg), Dose Expansion Phase : IV solution
Sponsors
Akihiro Inoguchi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The clinical sites will screen for the full inclusion criteria per protocol. 1. Sign and date the informed consent form (ICF) 2. Adults >=18 years at the time the ICF is signed 3. Has a histologically or cytologically documented, locally advanced, metastatic, or unresectable solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available 4. Has at least 1 measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) 5. Is willing and able to provide tumor tissue (newly obtained or archival) 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 7. Life expectancy >=3 months 8. Has a left ventricular ejection fraction (LVEF) >=50% within 28 days prior to Cycle 1 Day 1 9. Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) as prespecified in the protocol 10. If the participant is a female of childbearing potential, she must have a negative highly sensitive pregnancy test within 7 days prior to study drug administration (Cycle 1 Day 1) and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug 11. If male, the participant must avoid donating sperm and willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 4 months following the last dose of study drug 12. 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/or hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria.
Exclusion criteria
Exclusion criteria: 1. Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day1) as prespecified in the protocol 2. Has history of or current presence of untreated central nervous system (CNS) metastases 3. Has a history of leptomeningeal carcinomatosis 4. Has a history of (non-infectious) interstitial lung disease (ILD) other than radiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening 5. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses 6. Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, arterial thromboembolic event, or pulmonary embolism 7. Has uncontrolled or clinically significant cardiovascular disease 8. Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents) 9. Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal tract curatively resected by endoscopic surgery, or any other solid tumors curatively treated with no evidence of recurrent disease for >=3 years 10. Has unresolved toxicities from previous anticancer treatment, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCICTCAE) Version (v)5.0, Grade <=1 or baseline 11. Exposure to another investigational medical product within 4 weeks prior to Cycle 1 Day 1 or current participation in other therapeutic investigational procedures 12. Has any known contraindication to treatment with, including hypersensitivity to the study drug substances or inactive ingredients in the study drug product 13. Has an active, known, or suspected autoimmune disease 14. Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection 15. Has an active hepatitis or uncontrolled hepatitis B or C infection, except for participants with hepatitis B infection that is controlled by antiviral therapy 16. Has human immunodeficiency virus (HIV) infection with exceptions per protocol for participants in Dose Expansion 17. Has received a live, attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1) 18. Female who is pregnant or breastfeeding 19. Has psychological, social, familial, or geographical factors that would prevent regular follow-up 20. Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results Patients with hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Dose Escalation Part: To evaluate thesafety and tolerabilityof DS-1471a anddetermine the MTDand/or RDE(s) Dose Expansion Phase: To evaluate theoverall safety of DS-1471a at the RDE(s) | — |
Countries
Belgium, France, Japan, Spain, United States
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed