Trial Title:
A Study of DS-1471a In Subjects With Advanced Solid Tumors
NCT ID:
NCT06074705
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced Solid Tumor
DS-1471a
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DS-1471a
Description:
Intravenous administration on Day 1 of each 28-day cycle
Arm group label:
Part 1, Dose Escalation Cohort 1: DS-1471a
Arm group label:
Part 1, Dose Escalation Cohort 2: DS-1471a
Arm group label:
Part 1, Dose Escalation Cohort 3: DS-1471a
Arm group label:
Part 1, Dose Escalation Cohort 4: DS-1471a
Arm group label:
Part 1, Dose Escalation Cohort 5: DS-1471a
Arm group label:
Part 1, Dose Escalation Cohort 6: DS-1471a
Arm group label:
Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471a
Arm group label:
Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471a
Arm group label:
Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471a
Summary:
This first-in-human (FIH) study will assess the safety, preliminary efficacy,
pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or
metastatic solid tumors.
Detailed description:
The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation
and dose-expansion, FIH study of participants with locally advanced or metastatic solid
tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for
expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
The clinical site will screen for the full inclusion criteria per protocol.
- Sign and date the informed consent form (ICF)
- Adults ≥18 years at the time the ICF is signed
- 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
- Has at least 1 measurable lesion according to RECIST v1.1
- Is willing and able to provide tumor tissue (newly obtained or archived)
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy ≥3 months
- Has a left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to Cycle 1
Day 1
- Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) as
prespecified in the protocol
- If the participant is a female of childbearing potential, she must have a negative
serum 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
- If male, the participant must be surgically sterile or willing to use highly
effective birth control upon enrollment, during the Treatment Period, and for 4
months following the last dose of study drug
- 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 liver cancer may be eligible to participate if
they meet additional protocol specified criteria
Key Exclusion Criteria:
The clinical site will screen for the full exclusion criteria per protocol.
- Has an inadequate treatment washout period prior to start of study treatment (Cycle
1 Day 1) as prespecified in the protocol
- Has history of or current presence of untreated central nervous system (CNS)
metastases
- Has a history of leptomeningeal carcinomatosis
- 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
- Has a history of severe pulmonary compromise or requirement of supplemental oxygen
within 6 months before enrollment
- Has any of the following within the past 6 months: cerebrovascular accident,
transient ischemic attack, arterial thromboembolic event, or pulmonary embolism
- Has uncontrolled or clinically significant cardiovascular disease
- Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)
- Has multiple primary malignancies, except adequately resected non-melanoma 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
- Has unresolved toxicities from previous anticancer treatment
- Exposure to another investigational medical product within 4 weeks prior to Cycle 1
Day 1 or current participation in other therapeutic investigational procedures
- Has an active, known, or suspected autoimmune disease
- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has an active hepatitis or uncontrolled hepatitis B or C infection, except for HCC
participants with hepatitis B infection that is controlled by antiviral therapy
- Has human immunodeficiency virus (HIV) infection, with exceptions per protocol for
participants in Dose Expansion
- 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)
- Female who is pregnant or breastfeeding or intends to become pregnant during the
study
- Has psychological, social, familial, or geographical factors that would prevent
regular follow-up
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
See Central Contact
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
See Central Contact
Start date:
August 4, 2023
Completion date:
June 1, 2027
Lead sponsor:
Agency:
Daiichi Sankyo Co., Ltd.
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074705
