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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04145622
Other study ID # DS7300-A-J101
Secondary ID 194992
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 3, 2019
Est. completion date March 1, 2027

Study information

Verified date May 2024
Source Daiichi Sankyo
Contact (Japan sites) Daiichi Sankyo Contact for Clinical Trial Informat
Phone +81-3-6225-1111(M-F 9-5 JST)
Email dsclinicaltrial@daiichisankyo.co.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is in one single group of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: - Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). - Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date March 1, 2027
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. - Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by Investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the Investigator - Has adequate cardiac, hematopoietic, renal and hepatic functions - Has an adequate treatment washout period prior to start of study treatment - Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (primary neuroendocrine or histologically confirmed neuroendocrine differentiated prostate cancer is not allowed), breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Exclusion Criteria: - Has prior treatment with B7-H3 targeted agent, including I-DXd. - Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., trastuzumab deruxtecan) due to treatment-related toxicities. - Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery. - Uncontrolled significant cardiovascular disease - Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement, prior pneumonectomy, or requirement for supplemental oxygen - Has an uncontrolled infection requiring systemic therapy. - Has substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the Investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ifinatamab deruxtecan (I-DXd)
A total anti-B7H3 antibody and MAAA-1181a

Locations

Country Name City State
Japan Aichi Cancer Center Hospital Aichi
Japan National Cancer Center Hospital East Chiba
Japan Osaka University Hospital Osaka
Japan Saitama Cancer Center Saitama
Japan Shizuoka Cancer Center Hospital and Research Institute Shizuoka
Japan Cancer Institute Hospital of JFCR Tokyo
Japan National Cancer Center Hospital Tokyo
Japan Showa University Hospital Tokyo
United States Dana Farber Cancer Institute Boston Massachusetts
United States The Ohio State University Columbus Ohio
United States Sarah Cannon Research Institute at HealthONE Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States MDACC (MD Anderson Cancer Center) Houston Texas
United States Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute Los Angeles California
United States SCRI Oncology Partners Nashville Tennessee
United States Tennessee Oncology Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Florida Cancer Specialists Orlando Florida
United States Sidney Kimmel Cancer Center - Thomas Jefferson Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri
United States Florida Cancer Specialists Sarasota Florida

Sponsors (2)

Lead Sponsor Collaborator
Daiichi Sankyo Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the incidence of dose-limiting toxicities (DLTs) Day 1 to Day 21 in Cycle 1 in the dose escalation part
Primary Evaluate the incidence of adverse events (AEs) Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Primary Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd) Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Characterize the PK parameter AUClast Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Characterize the PK parameter AUCtau Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Characterize the PK parameter Cmax Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Characterize the PK parameter Tmax Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Characterize the PK parameter Ctrough Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Secondary Assess the incidence of anti-drug antibodies (ADAs) Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
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