Advanced Solid Tumor, Metastatic Solid Tumor
Conditions
Keywords
DS-3939a, Advanced/metastatic solid tumors, Antibody drug conjugate
Brief 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).
Interventions
DRUGDS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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 * Is able to provide either of the following baseline tumor samples: 1. 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 * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual. 2. 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 any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. * 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 (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a | Approximately 3 months after first dosing |
| Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a | Up to approximately 31 months |
| Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2) | Up to approximately 31 months |
| PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only) | Up to approximately 31 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1) | Up to approximately 31 months |
| Disease Control Rate Following Treatment With DS-3939a | Up to approximately 31 months |
| Duration of Response Following Treatment With DS-3939a | Up to approximately 31 months |
| Time to Response Following Treatment With DS-3939a | Up to approximately 31 months |
| Progression Free Survival Following Treatment With DS-3939a | Up to approximately 31 months |
| Overall Survival Following Treatment With DS-3939a | Up to approximately 31 months |
| TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a | At Cycle 1 Day 1 |
| Area Under the Plasma Concentration Curve (AUC) Following Treatment With DS-3939a | 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 | 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 | 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 | 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 | 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 | Up to approximately 47 months |
| PSA50 Response Rate Following Treatment with DS-3939a (Part 1; CRPC only) | Up to approximately 31 months |
| PSA30 and PSA90 Response Rate Following Treatment with DS-3939a (CRPC only) | Up to approximately 31 months |
| Time to PSA Progression Following Treatment with DS-3939a (CRPC only) | Up to approximately 31 months |
| Radiographic Progression-free Survival (PCWG 3) Following Treatment with DS-3939a (CRPC only) | Up to approximately 31 months |
| Overall Survival Following Treatment with DS-3939a (CRPC only) | Up to approximately 31 months |
Countries
Belgium, Canada, China, France, Japan, South Korea, Spain, United States
Contacts
CONTACT(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
STUDY_DIRECTORGlobal Clinical Leader
Daiichi Sankyo
Outcome results
None listed