Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HWK-007 · 1 trial · 7 indications
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...
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HWK-007 is an investigational small molecule being developed for the treatment of endometrial cancer. It is also being studied in other advanced solid tumors, including ovarian cancer and non-squamous EGFR wild-type non-small cell lung cancer. The drug is currently in Phase 1 clinical development.
HWK-007 targets PTK7, a protein involved in tumor growth and progression. It is designed as a PTK7-directed antibody drug conjugate, which means it delivers a cytotoxic agent to cancer cells that express PTK7. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors.
HWK-007 is being developed by Whitehawk Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol WHWK. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of HWK-007 in participants with advanced solid tumors.
HWK-007 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety, tolerability, and preliminary efficacy of HWK-007 in advanced solid tumors.
HWK-007 is being studied in a Phase 1 clinical trial with the identifier NCT07444814. This trial is evaluating the safety and efficacy of HWK-007 in participants with advanced solid tumors, including endometrial cancer, ovarian cancer, and non-squamous EGFR wild-type non-small cell lung cancer. The trial is currently recruiting in the United States.