First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation (Part 1) Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a. |
Drug: DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
|
| Experimental: Dose Expansion (Part 2) Multiple expansion cohorts targeting various advanced solid tumors. |
Drug: DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Sign and date the Informed Consent Form (ICF).
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Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
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Has adequate organ function.
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Measurable disease based on RECIST V1.1.
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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 urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.
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.
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Is able to provide either of the following baseline tumor samples:
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Fresh core needle biopsy samples obtained during the Screening Period, or
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Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF
Exclusion Criteria:
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Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
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Has spinal cord compression or history of/clinically active central nervous system metastases.
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Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
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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.
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Has active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count.
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Has evidence of active hepatitis B virus or hepatitis C virus infection.
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Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
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Has an active, known, or suspected autoimmune disease.
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Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DS3939-077