Advanced CancerPhase 1NCT05394675
A Study of DS-9606a in Patients With Advanced Solid Tumors
A Phase 1 study testing DS-9606a in people with Advanced Cancer and Metastatic Cancer, run by Daiichi Sankyo at 7 sites in 2 countries.
Trial summary
This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Germ Cell Tumor
- What is being tested?
- DS-9606a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 31 May 2022to 6 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
SCRI at HealthONE
Denver, Colorado, 80216
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida, 33916
MD Anderson Cancer Center
Houston, Texas, 77030
SCRI Oncology Partners
Nashville, Tennessee, 37203
United Kingdom2 sites
Sarah Cannon Research Institute UK
London, W1G 6AD
The Royal Marsden NHS Trust
Sutton, SM2 5PT
About this study
Official title: A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
Read the 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
- Being tested
- DS-9606a
- Keywords
- Advanced Cancer, Metastatic Cancer, DS-9606a, Germ Cell Tumor
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-9606aDrug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: DS-9606a | Experimental | Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks. Receives: Drug: DS-9606a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a
Measured: 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)
Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a
Measured: 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)
Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a
Measured: 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)
Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a
Measured: 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)
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA
Measured: Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and every 4 cycles thereafter on Day 1, up to 42 months (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start31 May 2022
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Why it stopped: It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394675
- Sponsor's protocol ID
- DS9606-137
- Other IDs
- 2022-000120-38, REFMAL 823
- Status last verified
- Mar 2026
- First submitted
- 24 May 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
- ClinicalTrials.gov ID
- NCT05394675
- Acronym / sponsor ID
- DS9606-137
- Conditions
- Advanced Cancer, Metastatic Cancer, Germ Cell Tumor
- Keywords
- Advanced Cancer, Metastatic Cancer, DS-9606a, Germ Cell Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: DS-9606a | Experimental | Drug: DS-9606aParticipants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-9606aIntravenous infusion | Drug | Dose Escalation: DS-9606a |
Primary outcome
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a
Time frame: 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
Time frame: Cycle 1 Day 1 to 90 days after last dose, up to 42 months (each cycle is 21 days)
10 secondary outcomes
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: 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)
Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: 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)
Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: 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)
Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a
Time frame: 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)
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA
Time frame: Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and every 4 cycles thereafter on Day 1, up to 42 months (each cycle is 21 days)
Results and safety
The study was stopped early (reason given: It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director study director
Daiichi Sankyo
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS-9606a in people with Advanced Cancer and Metastatic Cancer, run by Daiichi Sankyo at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was Daiichi Sankyo, Inc.'s decision to discontinue further internal development of DS-9606a). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a (time frame: Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.