CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 250 target
Drug / intervention
Ifinatamab deruxtecan (I-DXd)drug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓ECOG Performance Status 0 or 1
  • ✓At least 1 measurable lesion per RECIST 1.1 on CT or MRI
  • ✓Adequate cardiac, hematopoietic, renal and hepatic functions
  • ✓Adequate treatment washout period prior to study start
Key exclusion· 7
  • ✕Prior treatment with B7-H3 targeted agent, including I-DXd
  • ✕Prior discontinuation of ADC with exatecan derivative due to treatment-related toxicities
  • ✕Multiple primary malignancies within 3 years (except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial GI tract tumors, non-muscle invasive bladder cancer)
  • ✕Uncontrolled significant cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04145622
NCT04145622Phase 2RecruitingHigh Momentum
Long Recruiting
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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)

Daiichi Sankyo·interventional·Posted Oct 30, 2019·Updated May 29, 2026

In Brief

A Phase 2 clinical trial evaluating Ifinatamab deruxtecan (I-DXd) for Advanced Solid Tumor and Malignant Solid Tumor. Currently recruiting, targeting 250 participants across 28 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor, Malignant Solid Tumor
CountriesJapan, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2Recruiting
20202021202220232024202520262027202820292030
First PostedOct 30, 2019
Enrollment StartNov 3, 2019
Primary CompletionApr 30, 2027
Study CompletionOct 31, 2029
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 6.7 years agoPrimary completion in 10 months

Interventions

Ifinatamab deruxtecan (I-DXd)drug

A total anti-B7H3 antibody and MAAA-1181a