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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875168
• Other study ID #: DS3939-077
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 18, 2023
• Est. completion date: July 11, 2027

Study information

• Verified date: May 2024
• Source: Daiichi Sankyo
• Contact: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
• Phone: 908-992-6400
• Email: CTRinfo[@]dsi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: July 11, 2027
• Est. primary completion date: March 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

• Is able to provide either of the following baseline tumor samples:

• Fresh core needle biopsy samples obtained during the Screening Period, or

• 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:

• 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 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.

• 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 human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count.

• Has evidence of active 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Chiba
Japan	National Cancer Center Hospital	Tokyo
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a		Approximately 3 months after first dosing
Primary	Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a		Up to approximately 31 months
Primary	Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)		Up to approximately 31 months
Secondary	Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)		Up to approximately 31 months
Secondary	Disease Control Rate Following Treatment With DS-3939a		Up to approximately 31 months
Secondary	Duration of Response Following Treatment With DS-3939a		Up to approximately 31 months
Secondary	Time to Response Following Treatment With DS-3939a		Up to approximately 31 months
Secondary	Progression Free Survival Following Treatment With DS-3939a		Up to approximately 31 months
Secondary	Overall Survival Following Treatment With DS-3939a		Up to approximately 31 months
Secondary	TA-MUC1 Expression by Immunohistochemistry Following Treatment With DS-3939a		At Cycle 1 Day 1
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of Participants With Treatment-emergent Anti-drug Antibodies Following Treatment With DS-3939a		Up to approximately 47 months