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Also known as HWK-007 anti-PTK7 targeted ADC
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 studied for the treatment of endometrial cancer. It is also being evaluated in other advanced solid tumors, including ovarian cancer and non-squamous EGFR wild-type NSCLC. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
HWK-007 targets PTK7, a protein involved in tumor growth. It is designed as a PTK7-directed antibody drug conjugate, which means it delivers a cytotoxic agent to cells expressing PTK7. This mechanism is being studied in patients with advanced solid tumors, including endometrial cancer.
HWK-007 is being developed by Whitehawk Therapeutics, Inc., a biopharmaceutical company traded 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 and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants to assess the safety and efficacy of HWK-007 in advanced solid tumors.
HWK-007 is being studied in a single 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 NSCLC. The trial is currently recruiting in the United States.
HWK-007 is described as a PTK7-directed antibody drug conjugate, which is a type of targeted therapy that combines an antibody with a cytotoxic drug. Although HWK-007 is classified as a small molecule, its mechanism involves targeting PTK7 to deliver treatment directly to cancer cells.