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First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started2023-08-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Daiichi Sankyo

Amendment history

2026-09-30
Trial sites expanded: 36 → 61 locations
2026-08-11
Study Status, Contacts/Locations v19
Trial sites expanded: 33 → 36 locations
2026-07-15
Study Identification, Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v18
Primary endpoint(s) modified3 to 4 entries
WasNumber of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a, Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2), Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a
NowNumber of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a, Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2), Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a, PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)
Enrollment target540→590
Eligibility criteria+21 characters
[...] static, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy. Is able to provide either of the following baseline tumor s [...] Tissue Screening Period, or Fresh core needle biopsy sample BiopsyFresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, (ifor other procedures as long as the sample amount is equivalent to core needle biopsy and p [...] llows the procedure described in the Study Laboratory Manual). FFPE tumor tissue samples obtained by biopsy or [...] [...]
Secondary endpoints13 to 18 entries
PSA50 Response Rate Following Treatment with DS-3939a (Part 1; CRPC only) PSA30 and PSA90 Response Rate Following Treatment with DS-3939a (CRPC only) Time to PSA Progression Following Treatment with DS-3939a (CRPC only) Radiographic Progression-free Survival (PCWG 3) Following Treatment with DS-3939 [...]
2026-04-16
Study Status, Contacts/Locations v17
Primary completion pushed: 2026-03-17 → 2026-10-20
Study sites32→33
2026-01-09
Study Status, Contacts/Locations v16
Study sites27→32
Show 15 earlier versions
2025-12-11
Study Status, Contacts/Locations v15
Study sites24→27
2025-09-25
Study Status, Study Design, Eligibility, Contacts/Locations v14
Completion date2027-07-11→2027-02-15
Enrollment target470→540
Eligibility criteria+88 characters
[...] umor tissue samples obtained by biopsy or surgery performed afterwithin 6 months before signing the completionmain dateICF. If samples were obtained prior to the start of the most recent anticancer therapy regimen and within 6 months before signing, the ICFSponsor Medical Monitor should be consulted regarding the adequacy of the sample. Exclusion Criteria: Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. Has spinal cord compression or history of/clinically active central nervous system metastases. Has mul [...]
Study sitesdetails revised at 1 of 24 sites
2025-09-03
Study Status, Oversight, Contacts/Locations v13
Study sitesdetails revised at 1 of 24 sites
2025-07-29
Study Status, Oversight, Contacts/Locations v12
Study sitesdetails revised at 3 of 24 sites
2025-05-12
Study Status, Contacts/Locations v11
Study sites20→24
2025-02-18
Study Status, Contacts/Locations v10
Study sites14→20
2025-01-29
Study Status, Study Design, Eligibility v9
Enrollment target430→470
Eligibility criteria+170 characters
[...] ly documented locally advanced, metastatic, or unresectable urothelial,solid non-smallmalignant cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypestumors. Additional inclusion criteria for Part 2 Has a histologica [...] to provide either of the following baseline tumor samples: Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or Fresh core needle biopsy sample Biopsy samples obtained duringwith forceps or cryobiopsy, such as bronc [...] [...]
2024-10-21
Study Status, Contacts/Locations v8
Study sites5→14
2024-05-09
Study Status, Contacts/Locations v7
Study sites6→5
2024-03-29
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 6 sites
2024-01-08
Study Status, Eligibility v5
Eligibility criteria+5 characters
Inclusion Criteria: Sign and date the main Informed Consent Form (ICF). Has a left ventricular ejectio [...]
2023-12-15
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 6 sites
2023-09-15
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 6 sites
2023-08-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09→confirmed 2023-08-18
Study sitesdetails revised at 6 of 6 sites
2023-08-09
Study Status, Contacts/Locations v1
Study sites0→6
2023-05-12
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Trial Details
NCT Number NCT05875168
Lead Sponsor Daiichi Sankyo
Conditions Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 590 participants
Start Date 2023-08-18
Primary Completion 2026-10-20 (estimated)
Study Completion 2027-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-29