Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07540572 | A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 160 | — | — | Mar 17, 2026 | Jun 30, 2030 | May 20, 2026 | 10 | United States |
incidence of DLT; incidence and severity of AEs/serious adverse events (SAEs) graded based on CTCAE V6.0
Incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Incidence of DLT; incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Incidence and severity of AEs/SAEs graded based on CTCAE V6.0
Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response
| Arm | Type | Description |
|---|---|---|
| Monotherapy Dose Escalation (Part 1A) | EXPERIMENTAL | Participants with the appropriate tumor types will be treated with escalating doses of IDE574 |
| Monotherapy Dose Expansion (Part 1B) | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574 |
| Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant |
| Combination Dose Expansion (Part 2B) | EXPERIMENTAL | Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant |
| Name | Type | Description |
|---|---|---|
| IDE574 | DRUG | IDE574 |
| Fulvestrant injection | DRUG | Fulvestrant Injection |
Inclusion Criteria: Archival Tissue sample for testing * Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective ...