A Study of DS-9606a in Patients With Advanced Solid Tumors

NCT ID: NCT05394675

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2026-02-19

Brief Summary

This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.

Detailed Description

This is a first-in-human, phase 1, dose escalation study of the anti-CLDN6 ADC, DS-9606a, given as a single agent to patients with solid tumors. The primary objectives are to investigate the safety and tolerability of DS-9606a and to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDE/RDEs) in advanced solid tumors.

The secondary objectives of the study are to assess the pharmacokinetic properties and immunogenicity of DS-9606a, investigate the objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR) and progression free survival (PFS) of DS-9606a, according to RECIST v1.1.

Conditions

Advanced Cancer; Metastatic Cancer; Germ Cell Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation: DS-9606a

Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.

Group Type: EXPERIMENTAL

DS-9606a

Intervention Type: DRUG

Intravenous infusion

Interventions

DS-9606a

Intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• At least 18 years old at the time of written informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Availability of archived tumor tissue samples; patients with germ cell tumors without archived tumor samples may be allowed with approval
• Has a left ventricular ejection fraction (LVEF) ≥50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment
• Adequate bone marrow and organ function within 7 days before the start of study treatment
• Life expectancy ≥3 months
• Adequate treatment washout period prior to start of study treatment
• Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 6 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 6 months after final administration of study drug. Investigators will advise male patients on the conservation of sperm prior to study treatment. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration.
• Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer
• Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment.

Exclusion Criteria

• Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery ≥4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment
• Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled
• History of myocardial infarction or unstable angina within 6 months before study treatment
• Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
• Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read
• Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Has an uncontrolled infection requiring ongoing or long-term therapy
• Has a known active hepatitis or uncontrolled hepatitis B or C infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Director

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

SCRI at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Sarah Cannon Research Institute UK

London, , United Kingdom

The Royal Marsden NHS Trust

Sutton, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

2022-000120-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REFMAL 823

Identifier Type: OTHER

Identifier Source: secondary_id

DS9606-137

Identifier Type: -

Identifier Source: org_study_id