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

NCT06074705 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: DS1471-0792024-517984-21-00jRCT2031230234
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor; DS-1471a

Outcome Measures

Primary Outcomes (2)

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

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

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

  Baseline up to 60 months

Secondary Outcomes (12)

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

  Baseline up to 60 months

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

  Baseline up to 60 months

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

  Baseline up to 60 months

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

  Baseline up to 60 months

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

  Baseline up to 60 months

Study Arms (9)

Part 1, Dose Escalation Cohort 1: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 1, Dose Escalation Cohort 2: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 1, Dose Escalation Cohort 3: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 1, Dose Escalation Cohort 4: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 1, Dose Escalation Cohort 5: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 1, Dose Escalation Cohort 6: DS-1471a

EXPERIMENTAL

Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.

Drug: DS-1471a

Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471a

EXPERIMENTAL

Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.

Drug: DS-1471a

Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471a

EXPERIMENTAL

Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.

Drug: DS-1471a

Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471a

EXPERIMENTAL

Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.

Drug: DS-1471a

Interventions

DS-1471a DRUG

Intravenous administration on Day 1 of each 28-day cycle

Part 1, Dose Escalation Cohort 1: DS-1471a; Part 1, Dose Escalation Cohort 2: DS-1471a; Part 1, Dose Escalation Cohort 3: DS-1471a; Part 1, Dose Escalation Cohort 4: DS-1471a; Part 1, Dose Escalation Cohort 5: DS-1471a; Part 1, Dose Escalation Cohort 6: DS-1471a; Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471a; Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471a; Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (5)

Florida Cancer Specialist

Sarasota, Florida, 34236, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: August 4, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (3); US (2)