Actively Recruiting
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Led by Daiichi Sankyo · Updated on 2026-01-28
250
Participants Needed
25
Research Sites
521 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single group study 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.
CONDITIONS
Official Title
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- At least 1 measurable lesion according to RECIST Version 1.1 on CT or MRI as assessed by Investigator.
- Measurable lesions should not be from a previously irradiated site unless significant progression is documented.
- Adequate cardiac, hematopoietic, renal, and hepatic functions.
- Adequate treatment washout period before starting study treatment.
- Pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, adenocarcinoma CRPC (excluding neuroendocrine types), or breast cancer refractory or intolerable to standard treatments or without standard options.
- For Expansion Cohort 4 2L ESCC participants: disease progression after platinum-based and immune checkpoint inhibitor treatment, with up to one prior systemic therapy line for advanced/metastatic ESCC.
You will not qualify if you...
- Prior treatment with a B7-H3 targeted agent, including I-DXd.
- Prior discontinuation of an antibody drug conjugate with an exatecan derivative due to treatment-related toxicities.
- Multiple primary malignancies within 3 years except certain non-melanoma skin cancers, treated in situ diseases, superficial GI tract tumors, and non-muscle invasive bladder cancer treated endoscopically.
- Uncontrolled significant cardiovascular disease.
- Severe lung problems from other illnesses, autoimmune, connective tissue, or inflammatory disorders affecting lungs, prior pneumonectomy, or need for supplemental oxygen.
- Uncontrolled infection requiring systemic therapy.
- Substance abuse or other medical conditions increasing safety risks or interfering with study participation or evaluation, per investigator opinion.
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Withdrawn
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Florida Cancer Specialists
Orlando, Florida, United States, 32804
Withdrawn
4
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Active, Not Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Active, Not Recruiting
8
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
10
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
11
The Ohio State University
Columbus, Ohio, United States, 43210
Withdrawn
12
Sidney Kimmel Cancer Center - Thomas Jefferson
Philadelphia, Pennsylvania, United States, 19107
Withdrawn
13
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
14
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
MDACC (MD Anderson Cancer Center)
Houston, Texas, United States, 77030
Active, Not Recruiting
16
Aichi Cancer Center Hospital
Aichi, Japan, 464-8681
Actively Recruiting
17
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Actively Recruiting
18
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Actively Recruiting
19
Osaka University Hospital
Osaka, Japan, 565-0871
Actively Recruiting
20
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Actively Recruiting
21
Saitama Cancer Center
Saitama, Japan, 362-0806
Actively Recruiting
22
Shizuoka Cancer Center Hospital and Research Institute
Shizuoka, Japan, 411-8777
Actively Recruiting
23
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
24
Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
25
Showa University Hospital
Tokyo, Japan, 142-8666
Actively Recruiting
Research Team
(
(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
(
(US sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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