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Advanced Solid TumorPhase 1NCT06074705

A Study of DS-1471a In Subjects With Advanced Solid Tumors

A Phase 1 study testing DS-1471a in people with Advanced Solid Tumor, run by Daiichi Sankyo Co., Ltd. at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
DS-1471a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesin 2 countries
Study dates
4 Aug 2023to 29 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 1 on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Is willing and able to provide tumor tissue (newly obtained or archived)
Show all 18Show fewer
  • 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
  • A female participant of childbearing potential is eligible to participate if the following conditions are met:
  • Not pregnant as confirmed by highly sensitive pregnancy test within 7 days prior to study drug administration (Cycle 1 Day 1)
  • Agrees to adhere to a highly effective contraceptive method and agrees not to donate eggs or freeze/store eggs, during the intervention period, and for 7 months following the last dose of study drug
  • A male participant is eligible to participate if he agrees to the following during the intervention period and for 4 months following the last dose of study drug:
  • Avoid donating sperm
  • Adhere to either abstinence or use of a condom during intercourse with a nonparticipant of childbearing potential PLUS partner use of an additional contraceptive method
  • 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

Who cannot join

  • 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
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Show all 20Show fewer
  • 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 participants with hepatitis B infection that is controlled by antiviral therapy
  • For the Dose Escalation phase, has human immunodeficiency virus (HIV) infection. For the Dose Expansion phase, has active or uncontrolled HIV infection with exceptions per protocol.
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Japan3 sites

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

United States2 sites

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Florida Cancer Specialist

    Sarasota, Florida, 34236

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, First-in-human Study of DS-1471a In Subjects With Advanced Solid Tumors

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.

Read the 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.

Being tested
DS-1471a
Keywords
Advanced Solid Tumor, DS-1471a

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-1471aDrug

    Intravenous administration on Day 1 of each 28-day cycle

Study groups in NCT06074705
Study groupRoleWhat they receive
Part 1, Dose Escalation Cohort 1: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 1, Dose Escalation Cohort 2: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 1, Dose Escalation Cohort 3: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 1, Dose Escalation Cohort 4: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 1, Dose Escalation Cohort 5: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 1, Dose Escalation Cohort 6: DS-1471aExperimentalParticipants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Receives: Drug: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471aExperimentalParticipants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Receives: Drug: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471aExperimentalParticipants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Receives: Drug: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471aExperimentalParticipants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Receives: Drug: DS-1471a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)

    Measured: Cycle 1: Baseline up to Day 28 (each cycle is 28 days)

  2. Number of Participants With Treatment-emergent Adverse Events Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Measured: Baseline up to 60 months

Secondary outcomes (12)

  1. Best Overall Response (BOR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Best overall response (BOR) is recorded from the start of study drug until documented progressive disease (PD) or start of any anticancer treatment, whichever occurs first. Confirmation of complete response (CR) or partial response (PR) is required. As per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1, CR is defined as a disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions).

    Measured: Baseline up to 60 months

  2. Time to Response (TTR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Time to response (TTR) is defined as the time from the start of study drug to the date of the first documentation of response (CR or PR) as assessed by the investigator. As per RECIST v1.1, CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Baseline up to 60 months

  3. Duration of Response (DoR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Duration of response (DoR) is defined as the time from first documentation of CR or PR to the date of the first documentation of PD as assessed by the investigator or to the date of death due to any cause, whichever occurs first. As per RECIST v1.1, CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Baseline up to 60 months

  4. Progression-free Survival (PFS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Progression-free survival (PFS) is defined as the time from the start date of study drug to the date of the first documentation of objective PD as assessed by the investigator or to the date of death due to any cause, whichever occurs first. As per RECIST v1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Baseline up to 60 months

  5. Overall Survival (OS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)

    Overall survival (OS) is defined as the time from the date of the start of study drug to the date of death due to any cause.

    Measured: Baseline up to 60 months

  6. Objective Response Rate (ORR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)

    Confirmed objective response rate (ORR) is defined as the proportion of participants who have a confirmed BOR of CR or PR as assessed by the investigator. As per RECIST v1.1, CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Baseline up to 60 months

  7. Disease Control Rate (DCR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)

    Disease control rate (DCR) is defined as the proportion of participants who have a BOR of CR, PR, or SD as assessed by the investigator. As per RECIST v1.1, CR is defined as a disappearance of all target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions).

    Measured: Baseline up to 60 months

  8. Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) of DS-1471a

    Measured: Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days

  9. Pharmacokinetic Analysis Time to Reach Maximum Plasma Concentration (Tmax) of DS-1471a

    Measured: Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days

  10. Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve of DS-1471a

    Area under the plasma concentration-time curve up to the last quantifiable time (AUClast), area under the plasma concentration-time curve from the time of dosing to 28 day (AUC28d), and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.

    Measured: Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days

  11. Pharmacokinetic Analysis Trough Plasma Concentration (Ctrough) of DS-1471a

    Measured: Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days

  12. Percentage of Participants With Anti-Drug Antibodies Against DS-1471a

    Anti-drug antibodies (ADA) incidence is defined as the proportion of participants having treatment-emergent ADAs.

    Measured: Cycle 1 (Days 1 and 8), Cycle 2 and 3 (Day 1), and Cycle 4 and every 2 cycles thereafter (Day 1), each cycle is 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start4 Aug 2023
  3. Primary completion29 Jul 2025
  4. Study completion29 Jul 2025

Why it stopped: The study was terminated by the sponsor due to a business decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074705
Sponsor's protocol ID
DS1471-079
Other IDs
2024-517984-21-00, jRCT2031230234
Status last verified
Aug 2025
First submitted
29 Sep 2023
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DS-1471a in people with Advanced Solid Tumor, run by Daiichi Sankyo Co., Ltd. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated by the sponsor due to a business decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation) (time frame: Cycle 1: Baseline up to Day 28 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06074705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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