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DS-9606a for Cancer

Phase 1

Recruiting

Research Sponsored by Daiichi Sankyo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort B-1: Ovarian cancer

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial will study DS-9606a to see if it is safe and tolerated in patients with advanced solid tumors.

Who is the study for?

Adults with advanced solid tumors, including ovarian and germ cell cancers, who are in good physical condition (ECOG score of 0 or 1) can join. They must have a life expectancy over 3 months, proper heart function, and agree to contraception. Those with brain metastases treated successfully may qualify; however, individuals with recent serious heart issues or uncontrolled infections cannot participate.Check my eligibility

What is being tested?

The trial is testing DS-9606a's safety for patients with various advanced solid tumors. It will involve participants providing tissue samples before and during treatment to assess the drug's effects on their cancer.See study design

What are the potential side effects?

While specific side effects of DS-9606a are not listed here, common ones for cancer treatments include fatigue, nausea, risk of infection due to low blood counts, potential allergic reactions to the drug infusion, and possible organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have ovarian cancer.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My cancer is advanced or has spread and this was confirmed by a lab test.

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My organs and bone marrow are functioning well.

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I agree to give tissue samples before and during treatment, if it's safe for me.

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My cancer has worsened despite treatment, or I cannot tolerate/choose not to have standard treatment.

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I agree to use effective birth control or avoid sex during the study and for months after.

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My heart pumps well, with an ejection fraction of 50% or higher.

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My cancer is advanced or has spread, and includes types like ovarian, uterine, pancreatic, lung (non-squamous), or stomach cancer.

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My germ cell tumor has not responded to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a (Dose Expansion)

Secondary outcome measures

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

Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose Expansion: Cohort B-2Experimental Treatment1 Intervention

Participants with refractory germ cell tumors who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.

Group II: Dose Expansion: Cohort B-1Experimental Treatment1 Intervention

Participants with ovarian cancer who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.

Group III: Dose Escalation: DS-9606aExperimental Treatment1 Intervention

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

415,172 Total Patients Enrolled

Daiichi SankyoLead Sponsor

392 Previous Clinical Trials

411,240 Total Patients Enrolled

Clinical DirectorStudy DirectorDaiichi Sankyo

17 Previous Clinical Trials

4,370 Total Patients Enrolled

Media Library

DS-9606a (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05394675 — Phase 1

Germ Cell Tumors Research Study Groups: Dose Escalation: DS-9606a, Dose Expansion: Cohort B-1, Dose Expansion: Cohort B-2

Germ Cell Tumors Clinical Trial 2023: DS-9606a Highlights & Side Effects. Trial Name: NCT05394675 — Phase 1

DS-9606a (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394675 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does DS-9606a present any potential danger to users?

"The limited amount of available data concerning DS-9606a's efficacy and safety led to our team assigning it a score of 1."

Answered by AI

In what locations are the trials for this study taking place?

"Presently, the trial is running in 6 medical centres across the USA, including Detroit, Nashville and Sarasota. To minimize your transportation needs during participation it may be advantageous to select a clinic closest to you."

Answered by AI

To what extent has this research enrolled participants?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is actively recruiting participants since it was first posted on May 31st 2022 and recently updated on November 21st 2022. The investigators are targeting 125 patients across 6 distinct sites."

Answered by AI

Are individuals currently eligible to join this empirical investigation?

"As seen on clinicaltrials.gov, the trial is actively recruiting participants. It was first advertised on May 31st 2022 and has recently been updated (November 21st 2022)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of DS-9606a in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394675.