DS-9606a for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Florida Cancer Specialists & Research Institute, LLC, Sarasota, FL
Neoplasm Metastasis+6 More
DS-9606a - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study DS-9606a to see if it is safe and tolerated in patients with advanced solid tumors. The drug DS-9606a is being used to treat Neoplasm Metastasis in this trial, and there is no placebo group. This drug has previously been approved by the FDA for a different condition. The treatment is free for patients in this trial.

Eligible Conditions

  • Neoplasm Metastasis
  • Germ Cell Tumors
  • Cancer, Advanced
  • Ovarian Cancer
  • Metastatic Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neoplasm Metastasis

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days)

Month 36
Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a
Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a
Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a (Dose Expansion)
Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a
Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a
Day 21
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
Month 36
Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a
Month 36
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA
Month 36
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC)
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Pharmacokinetic Parameter Trough Concentration (Ctrough)

Trial Safety

Safety Progress

1 of 3

Other trials for Neoplasm Metastasis

Trial Design

3 Treatment Groups

Dose Escalation: DS-9606a
1 of 3
Dose Expansion: Cohort B-1
1 of 3
Dose Expansion: Cohort B-2
1 of 3
Experimental Treatment

125 Total Participants · 3 Treatment Groups

Primary Treatment: DS-9606a · No Placebo Group · Phase 1

Dose Escalation: DS-9606a
Drug
Experimental Group · 1 Intervention: DS-9606a · Intervention Types: Drug
Dose Expansion: Cohort B-1
Drug
Experimental Group · 1 Intervention: DS-9606a · Intervention Types: Drug
Dose Expansion: Cohort B-2
Drug
Experimental Group · 1 Intervention: DS-9606a · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: cycles 1-3, day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (cycles 1 and 3 only); cycle 1 and 3,day 2; cycle 1 and 3,days 4,8, and 15; cycle 2,days 8 and 15; cycle 4,day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days)
Closest Location: Florida Cancer Specialists & Research Institute, LLC · Sarasota, FL
Photo of florida 1Photo of florida 2Photo of florida 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Neoplasm Metastasis
0 CompletedClinical Trials

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor
349 Previous Clinical Trials
337,194 Total Patients Enrolled
5 Trials studying Neoplasm Metastasis
4,488 Patients Enrolled for Neoplasm Metastasis
Clinical DirectorStudy DirectorDaiichi Sankyo, Inc.
14 Previous Clinical Trials
3,739 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years old to give informed consent.
You have a performance status of 0 or 1.
Patients with germ cell tumors must have archived tumor tissue samples.
You have histologically- or cytologically-documented locally advanced or metastatic cancer.
You have metastatic disease and are either not eligible for standard treatment or refuse standard treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.