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

NCT05394675 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: DS9606-1372022-000120-38REFMAL 823
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Advanced Cancer; Germ Cell Tumor; Metastatic Cancer

Keywords

Advanced Cancer; Metastatic Cancer; DS-9606a; Germ Cell Tumor

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a

  Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a

  Cycle 1 Day 1 to 90 days after last dose, up to 42 months (each cycle is 21 days)

Secondary Outcomes (10)

• Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC)

  Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)

• Pharmacokinetic Parameter Maximum Concentration (Cmax)

  Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)

• Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)

  Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)

• Pharmacokinetic Parameter Trough Concentration (Ctrough)

  Cycles 1-5, Day 1:pre-dose, end of flush, 4 hrs & 8 hrs post-dose (Cycles 1,3, &5 only); Cycle 1 & 3,Day 2; Cycle 1 & 3,Days 4,8, & 15; Cycle 2,Days 8 & 15;Cycle 4 & 6, & up to Cycle 10,Day 1 & pre-dose every cycle, up to 42 months (each cycle = 21 days)

• Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a

  Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 42 months (each cycle is 21 days)

Study Arms (1)

Dose Escalation: DS-9606a

EXPERIMENTAL

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

Drug: DS-9606a

Interventions

DS-9606a DRUG

Intravenous infusion

Dose Escalation: DS-9606a

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (7)

SCRI at HealthONE

Denver, Colorado, 80216, United States

Location

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, 33916, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

The Royal Marsden NHS Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type

Study Officials

• Clinical Director

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: May 31, 2022
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

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

US (5); GB (2)