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

NCT04145622 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DS7300-A-J101194992
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 25

Brief 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.

Conditions

Advanced Solid Tumor; Malignant Solid Tumor

Keywords

Advanced Solid Tumor; Malignant Tumor; Ifinatamab deruxtecan (I-DXd)

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (6)

• Characterize the PK parameter AUClast

  Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

• Characterize the PK parameter AUCtau

  Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

• Characterize the PK parameter Cmax

  Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

• Characterize the PK parameter Tmax

  Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

• Characterize the PK parameter Ctrough

  Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)

Study Arms (2)

Dose escalation

EXPERIMENTAL

Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.

Drug: Ifinatamab deruxtecan (I-DXd)

Dose expansion

EXPERIMENTAL

Currently enrolling participants with advanced solid tumors who will receive I-DXd IV Q3W monotherapy at the recommended dose for expansion.

Drug: Ifinatamab deruxtecan (I-DXd)

Interventions

Ifinatamab deruxtecan (I-DXd) DRUG

A total anti-B7H3 antibody and MAAA-1181a

Dose escalation; Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (25)

Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

WITHDRAWN

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Florida Cancer Specialists

Orlando, Florida, 32804, United States

WITHDRAWN

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Washington University

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

WITHDRAWN

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

WITHDRAWN

Sidney Kimmel Cancer Center - Thomas Jefferson

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

MDACC (MD Anderson Cancer Center)

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Chiba, 277-8577, Japan

RECRUITING

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

RECRUITING

Osaka University Hospital

Osaka, 565-0871, Japan

RECRUITING

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

RECRUITING

Saitama Cancer Center

Saitama, 362-0806, Japan

RECRUITING

Shizuoka Cancer Center Hospital and Research Institute

Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, 104-0045, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

Showa University Hospital

Tokyo, 142-8666, Japan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Central Study Contacts

(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

+81-3-6225-1111(M-F 9-5 JST); dsclinicaltrial@daiichisankyo.co.jp

(US sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 30, 2019
• Study Start: November 3, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (10); US (15)