Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1/Phase 2

Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors

NCT ID: NCT05875168Sponsor: Daiichi SankyoLast updated: 2026-04-20

Summary

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Detailed description

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Arms & interventions

  • DrugDS-3939a

    One IV infusion Q3W on Day 1 of each 21-day cycle

Outcome measures

Primary

  • Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a

    Time frame: Approximately 3 months after first dosing

  • Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)

    Time frame: Up to approximately 31 months

Secondary

  • Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)

    Time frame: Up to approximately 31 months

  • Disease Control Rate Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • Duration of Response Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • Time to Response Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • Progression Free Survival Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • Overall Survival Following Treatment With DS-3939a

    Time frame: Up to approximately 31 months

  • TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a

    Time frame: At Cycle 1 Day 1

  • Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a

    Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  • Maximum Plasma Concentration (Cmax) Following Treatment With DS-3939a

    Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  • Time to Maximum Plasma Concentration (Tmax) Following Treatment With DS-3939a

    Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  • Minimum Observed Concentration (Ctrough) Following Treatment With DS-3939a

    Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  • Terminal Half-Life (T1/2) Following Treatment With DS-3939a

    Time frame: Cycles 1 & 3: Days 1, 2, 4, 8 & 15; Cycle 2: Day 1 & 1 time between Days 3 to 8 (Part 2 Only); Cycles 4 & every 2 cycles thereafter up to 31 months: Day 1 (each cycle is 21 days)

  • Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a

    Time frame: Up to approximately 47 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional inclusion criteria for Part 1 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional inclusion criteria for Part 2 * Has a histologically or cytologically documented locally advanced, metastatic, 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 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 with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual) * FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor 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 clinically active central nervous system metastases. * Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years. * Has a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. * Has active or uncontrolled human immunodeficiency virus (HIV) infection. * Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection. * Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. * Has an active, known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Study locations (6)

Florida Cancer Specialists

Sarasota, Florida, 34232

Recruiting
Principal Investigator · Contact

Oregon Health & Science University

Portland, Oregon, 97239

Recruiting

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting
Principal Investigator · Contact

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

Recruiting
Principal Investigator · Contact

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin, 53226

Recruiting

References

  • Takano K, Yukiura M, Takahashi K, Kitamura M, Okuno H, Shiose Y, Honda K, Oyama K, Yamada M, Obuchi W, Kumagai K, Sakurai K, Goto R, Zembutsu A, Kagari T, Abe Y, Agatsuma T. DS-3939a: A TA-MUC1-Directed Antibody-Drug Conjugate with Broad Antitumor Activity. Mol Cancer Ther. 2026 Jan 2;25(1):7-20. doi: 10.1158/1535-7163.MCT-24-0666.(PubMed)