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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07085091 | A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors | PHASE1 | RECRUITING | 170 | — | — | Aug 18, 2025 | Dec 1, 2027 | May 12, 2026 | 8 | United States |
Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation
Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing
Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR)
| Arm | Type | Description |
|---|---|---|
| ALX2004 Phase 1a (Dose Escalation) | EXPERIMENTAL | ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase |
| ALX2004 Phase 1a (Dose Exploration) | EXPERIMENTAL | ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase |
| ALX2004 Phase 1b (Dose Expansion) | EXPERIMENTAL | ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase |
| Name | Type | Description |
|---|---|---|
| ALX2004 | DRUG | ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion |
Inclusion Criteria: * Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent 1. Dose Escalation: Participants who have relapsed or progressed follow...