Study of Ifinatamab Deruxtecan for Advanced Solid Tumors
This study is testing a new drug called Ifinatamab deruxtecan (I-DXd) for people with advanced solid tumors that haven't been cured by other treatments. This is the first time this drug will be used in humans. Researchers want to see how safe it is, what side effects it might cause, and if it can shrink tumors. You might be able to join if you are 18 or older, have a good performance status (meaning you can do most daily activities), and have at least one measurable tumor. The study will look at side effects and tumor changes over about 8 cycles of treatment, with each cycle lasting 21 days.
- Study design
- This is a single group study with an estimated 250 participants. It has two parts: one to find the right dose and another to further investigate safety and anti-tumor activity.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will investigate anti-tumor activity and adverse events through disease progression within 8 cycles (each cycle is 21 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04145622
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentDaiichi Sankyo
~250 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Ifinatamab deruxtecan (I-DXd)
At a glance
Recruiting sites
16 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the incidence of dose-limiting toxicities (DLTs)
Measured over Day 1 to Day 21 in Cycle 1 in the dose escalation part
+2 more outcomes measured
Conditions
Where it's being run
28 sites across 13 statesJapan13
Florida2
New York2
Tennessee2
California1
Colorado1
Massachusetts1
Michigan1
Study leadership
- Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo
Who to contact
(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Has disease progression a post platinum-based and an immune checkpoint inhibitor (ICI) treatment per global or local guidelines, with a maximum of one prior line of systemic therapy for unresectable advanced or metastatic ESCC.
Exclusion
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.
What this trial measures
- Evaluate the incidence of dose-limiting toxicities (DLTs)Day 1 to Day 21 in Cycle 1 in the dose escalation part
- Evaluate the incidence of adverse events (AEs)Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
- Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd)Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)