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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07444814 | Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 226 | — | — | Dec 19, 2025 | Dec 1, 2028 | Mar 27, 2026 | 12 | United States |
Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation - 21 Day treatment cycle | EXPERIMENTAL | Escalating doses of HWK-007 administered intravenously (IV) |
| Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC | EXPERIMENTAL | Expanded enrolment at selected dose of HWK-007 in NSCLC. |
| Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD |
| Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Expanded enrolment at third selected dose in Tumor - TBD |
| Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Dose Expansion of HWK-007, a PTK7-directed ADC. |
| Name | Type | Description |
|---|---|---|
| HWK-007 | DRUG | HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors. |
Inclusion Criteria: Have one of the following solid tumor cancers: 1. Monotherapy escalation and backfill cohorts: 1. non-squamous EGFR-Wt NSCLC 2. Endometrial carcinoma 3. Platinum Resistant Ovarian Cancer 2. Monotherapy expansion cohorts: 1. Non-squamous EGFR-Wt NSCLC 2. Additio...