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| Name | Class |
|---|---|
| Catalyst Pharmaceutical Research | INDUSTRY |
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HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group.
The study consists of 2 parts (Part A: monotherapy and Part B: combination therapy with bevacizumab); each part has 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). Enrollment to Part A (Phase 1a and Phase 1b) will include ovarian and endometrial cancers. Enrollment to Part B (Phase 1a and Phase 1b) will include ovarian cancer only. A subsequent protocol amendment may evaluate additional tumor types.
HWK-016-101 is a Phase 1 study evaluating HWK-016, a mucin-16 (MUC-16) targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Dose Escalation - 21 Day treatment cycles | Experimental | Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) |
|
| Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD | Experimental | Dose Optimization of Recommended dose for expansion 1 |
|
| Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | Experimental | Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer |
|
| Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | Experimental | Expansion of enrolment at RDE 1 or 2 in Tumor TBD |
|
| Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab | Experimental | Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HWK-016, MUCIN-16-targeted ADC | Drug | HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine Maximum Tolerated Dose (MTD) | Determine the highest dose of HWK-016 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). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles) |
| Determine Maximum Administered Dose (MAD) | Determine the highest dose of HWK-016 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). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached. |
| Determine Recommended Dose For Expansion (RDE) | Determine the dose of HWK-016 that will be recommended for further study within the tumor types studied in this clinical trial, measured at the end of Cycle 1, Day 21 (21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer. | From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the Volume of Distribution (Vd) of HWK-016 (ADC, total antibody, CPT116, and CPT119) | Pharmacokinetic analysis of HWK-016 in human subjects | Cycle 1 and Cycle 4 (21-day cycles) |
| Maximum Concentration - Cmax of HWK-016 (ADC, total antibody, CPT116, and CPT119) |
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Inclusion Criteria:
Have one of the following solid tumor cancers:
Monotherapy escalation, backfill and expansion cohorts:
Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager Lead | Contact | 888-392-9025 | WHWK-Clinical-Trials@whitehawktx.com | |
| Central email mailbox - Whitehawk Therapeutics | Contact | WHWK-Clinical-Trials@whitehawktx.com |
| Name | Affiliation | Role |
|---|---|---|
| Margaret C Dugan, MD | Whitehawk Therapeutics | Study Director |
| Edward Spindler, BS, MBA | Whitehawk Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas - Winthrop P. Rockefeller Cancer Institute | Not yet recruiting | Little Rock | Arkansas | 72205 | United States |
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Dose escalation will use a BOIN design.
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| Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | Experimental | Expansion of enrolment at RDE 1 or 2 in Tumor TBD |
|
| Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab | Experimental | Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer |
|
| Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab | Experimental | Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD |
|
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| Bevacizumab | Drug | Bevacizumab administered according to the USPI in 21-day cycles |
|
Maximum amount of study drug and drug components in blood following infusion. |
| At Cycle 1 and Cycle 4 - (21-day cycles) |
| Time to Maximum Concentration (Tmax) of HWK-016 (ADC, total antibody, CPT116, and CPT119) | Time to reach maximum concentration of drug and drug components in blood following infusion. | Cycle 1 and Cycle 4 - (21-day cycles) |
| Area Under the Concentration Time Curve (AUC) for HWK-016 (ADC, total antibody, CPT116, and CPT119) | The total area under the concentration time curve of study drug and drug components following infusion | Cycle 1 and Cycle 4 - (21-day cycles |
| T1/2 - Half-life of HWK-016 (ADC, total antibody, CPT116, and CPT119) | Time for 1/2 of the infused drug to be eliminated/metabolized | Cycle 1 and Cycle 4 - (21-day cycles) |
| Clearance (CL) | Measured rate at which HWK-016 is cleared from the blood following infusion. | Cycle 1 and Cycle 4 (21-day cycles) |
| Assess ADA (Anti drug antibody) against HWK-016 | Using a blood test, determine the risk of developing anti-drug antibodies against HWK-016 following infusion in human patients. | Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months. |
| Evaluate the Overall Response Rate (ORR | Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1. Evaluate preliminary antitumor activity of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer by RECIST Version 1.1 | From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first. |
| Evaluate Overall Survival (OS). | Measure how long a patient lives following treatment with HWK-016. Evaluate the Overall Survival at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first. |
| Evaluate the Duration of Response (DoR) to HWK-016 | Measure the time from evidence of response by CT-scan until evidence of progression of cancer. Evaluate the Duration of Response at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first. |
| Evaluate Progression-free Survival (PFS) | Measure the time from the first infusion of HWK-007 until evidence of cancer progression is detected. Evaluate the Progression Free Survival at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months) |
| Evaluate Disease control Rate (DCR) | Measure the time from Cycle 1, Day 1 that cancer does not worsen by RECIST1.1 criteria. Evaluate the Disease Control Rate at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months |
| Time to Response (TTR) | Time from Cycle 1, Day 1 infusion of HWK-016 until evidence of response via CT scan according to RECIST1.1 criteria. Evaluate the Time to Response at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer | From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first |
| START - Los Angeles | Recruiting | Los Angeles | California | 90025 | United States |
|
| SCRI - Florida Cancer Specialists | Not yet recruiting | Sarasota | Florida | 34232 | United States |
|
| St. Francis Medical Center (OSF Healthcare) | Not yet recruiting | Peoria | Illinois | 61637 | United States |
|
| Karmanos Cancer Center | Not yet recruiting | Detroit | Michigan | 48201 | United States |
|
| Start - Ny | Recruiting | Lake Success | New York | 11042 | United States |
|
| Memorial Sloan Kettering Cancer Center | Not yet recruiting | New York | New York | 07920 | United States |
|
| Atrium Health - Wake Forest | Not yet recruiting | Charlotte | North Carolina | 282204 | United States |
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| Ohio State University Wexner Medical Center | Not yet recruiting | Columbus | Ohio | 43210 | United States |
|
| SCRI - Sydney Kimmel Cancer Center - Jefferson Health | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| SCRI - Mary Crowley Cancer Research | Not yet recruiting | Dallas | Texas | 75230 | United States |
|
| START Mountain | Recruiting | Salt Lake City | Utah | 84119 | United States |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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