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Testing Ifinatamab Deruxtecan in Patients with Advanced Solid Tumors

Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)

Phase1; Phase2 Interventional Daiichi Sankyo · NCT04145622

This study is testing a new drug called Ifinatamab Deruxtecan to see if it can help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorDaiichi Sankyo Industry-sponsored
Drugs / interventionstrastuzumab, ifinatamab
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT04145622 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) in patients with advanced solid tumors that have not responded to previous treatments. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to assess the drug's antitumor activity. Participants may continue treatment as long as they benefit from it, with the study expected to last approximately five years. The study aims to provide new treatment options for patients with difficult-to-treat cancers.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or unresectable solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients with tumors that have been previously treated with radiation at the only selectable target lesion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies using similar targeted therapies have shown promise, but this specific approach with Ifinatamab Deruxtecan is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

For Expansion Cohort 4 2L ESCC participants only:

* 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 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.

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorMalignant Solid TumorMalignant TumorIfinatamab deruxtecan
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.