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

NCT04145622 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-28

No results posted yet for this 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.

Conditions

  • Advanced Solid Tumor
  • Malignant Solid Tumor

Interventions

DRUG

Ifinatamab deruxtecan (I-DXd)

A total anti-B7H3 antibody and MAAA-1181a

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-03
Primary Completion
2027-04-30
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145622 on ClinicalTrials.gov