Ireland
--:--IST
Active, not recruiting Phase 1/2

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1/2
Started
2019-11-03
Last updated
2026-10-06

Condition(s) studied

Advanced Solid TumorMalignant Solid Tumor

Investigational drug(s) / intervention(s)

Ifinatamab deruxtecan (I-DXd) →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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)

Trial sites (23)

FacilityCityRegionStatus
Sarah Cannon Research Institute at HealthONE Denver Colorado
Florida Cancer Specialists Sarasota Florida
Dana Farber Cancer Institute Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Washington University St Louis Missouri
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
Memorial Sloan-Kettering Cancer Center New York New York
SCRI Oncology Partners Nashville Tennessee
Tennessee Oncology Nashville Tennessee
MDACC (MD Anderson Cancer Center) Houston Texas
Aichi Cancer Center Hospital Aichi Japan
National Cancer Center Hospital East Chiba Japan
Hokkaido University Hospital Hokkaido Japan
Kobe City Medical Center General Hospital Hyōgo Japan
Kagawa University Hospital Kagawa Japan
The University of Osaka Hospital Osaka Japan
Kindai University Hospital Ōsaka-sayama Japan
Saitama Cancer Center Saitama Japan
Shizuoka Cancer Center Shizuoka Japan
National Cancer Center Hospital Tokyo Japan
Cancer Institute Hospital of JFCR Tokyo Japan
Showa Medical University Hospital Tokyo Japan
Keio University Hospital Tokyo Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04145622 on ClinicalTrials.gov ↗ ← All trials in Japan