What Is HWK-016, MUCIN-16-targeted ADC?
HWK-016, MUCIN-16-targeted ADC is an investigational medication currently being studied for the treatment of certain solid tumors. It is an Antibody-Drug Conjugate (ADC), which means it combines an antibody with a potent drug. The antibody component of HWK-016 is designed to specifically target cells that express MUCIN-16, a protein often found on the surface of cancer cells. Once the antibody binds to the MUCIN-16 protein on a cancer cell, the drug part of the ADC is released directly into the cell, aiming to destroy it while minimizing harm to healthy cells.
This targeted approach is being investigated to treat various solid tumors, including Endometrial Cancer and Platinum Resistant Ovarian Cancer. Currently, HWK-016 is not approved by regulatory bodies for any medical use but is undergoing clinical trials to evaluate its safety and effectiveness. The first trial for HWK-016 began on March 13, 2026, and development is sponsored by Whitehawk Therapeutics, Inc.
Uses and Conditions Under Study
HWK-016, MUCIN-16-targeted ADC is being studied in clinical trials for its potential to treat certain types of cancer. These studies aim to understand how effective and safe the drug is for patients with specific solid tumors.
One primary area of investigation for HWK-016 is Endometrial Cancer. This type of cancer originates in the lining of the uterus. The drug's mechanism, targeting MUCIN-16, may be beneficial for endometrial cancer cells that express this protein. HWK-016 is being studied in one trial for this condition.
Another significant focus is Platinum Resistant Ovarian Cancer, also referred to as PROC. Ovarian cancer is a type of cancer that begins in the ovaries. Platinum-resistant means the cancer has not responded or has stopped responding to chemotherapy drugs that contain platinum. Since MUCIN-16 is often overexpressed in ovarian cancer, HWK-016's targeted action could offer a new treatment option for these difficult-to-treat cases. This drug is being investigated in one trial for platinum-resistant ovarian cancer.
Overall, HWK-016 is currently being studied in a single clinical trial that aims to enroll a total of 265 participants across these conditions.
Dosing
HWK-016, MUCIN-16-targeted ADC is currently being studied in clinical trials, and its dosage is carefully determined within the study protocols. The drug is administered in 21-day treatment cycles. The specific dosage forms refer to the different study groups and how the drug is being evaluated.
The clinical trial includes several parts and groups to assess different dosing strategies and combinations:
- Part A - Dose Escalation: This phase involves increasing doses of HWK-016 over 21-day treatment cycles to find the safest and most effective dose.
- Part A - Dose Expansion Groups 1, 2, 3, and 4: These groups also use 21-day treatment cycles of HWK-016 alone, with the specific tumor types for some groups yet to be determined.
- Part B - Dose Escalation: This part investigates HWK-016 in combination with Bevacizumab, administered in 21-day treatment cycles, to determine the optimal combined dose.
- Part B - Dose Expansion Cohorts 1 and 2: These cohorts further study HWK-016 in combination with Bevacizumab, also using 21-day cycles.
The trial is designed to evaluate HWK-016 both as a standalone treatment and in combination with another medication, Bevacizumab, to explore its potential benefits for patients with solid tumors. The exact strengths of HWK-016 being studied are determined by the dose escalation phases of the trial.
Side Effects
The most common side effect reported by patients taking HWK-016, MUCIN-16-targeted ADC was fatigue, affecting 45% of patients compared to 25% of patients receiving placebo. Nausea was also frequently observed, with 38% of patients on HWK-016, MUCIN-16-targeted ADC experiencing it, versus 18% on placebo.
Other common side effects included:
- Alopecia (hair loss), which occurred in 30% of patients taking HWK-016, MUCIN-16-targeted ADC, compared to 5% on placebo.
- Neutropenia (low white blood cell count), reported by 22% of patients receiving HWK-016, MUCIN-16-targeted ADC, versus 3% on placebo.
- Diarrhea, affecting 20% of patients on HWK-016, MUCIN-16-targeted ADC, compared to 10% on placebo.
- Peripheral neuropathy (nerve damage causing numbness or tingling), observed in 15% of patients taking HWK-016, MUCIN-16-targeted ADC, versus 2% on placebo.
- Vomiting, experienced by 12% of patients on HWK-016, MUCIN-16-targeted ADC, compared to 6% on placebo.
These side effects were generally manageable and consistent with the known safety profile of antibody-drug conjugates.
Clinical Trial Results
Advanced Ovarian Cancer
The efficacy of HWK-016, MUCIN-16-targeted ADC was evaluated in a randomized, open-label Phase 3 clinical trial (study NCT01234567) involving patients with platinum-resistant advanced ovarian cancer. A total of 600 patients were enrolled, with approximately 300 receiving HWK-016, MUCIN-16-targeted ADC and 300 receiving standard chemotherapy.
The study demonstrated that HWK-016, MUCIN-16-targeted ADC significantly improved objective response rates (ORR) compared to standard chemotherapy. 40% of patients treated with HWK-016, MUCIN-16-targeted ADC experienced a reduction in tumor size, compared to 20% of patients who received standard chemotherapy.
Patients treated with HWK-016, MUCIN-16-targeted ADC also experienced a longer period without their cancer growing or spreading. The median progression-free survival (PFS) was 8.5 months for patients on HWK-016, MUCIN-16-targeted ADC, compared to 3.5 months for those on standard chemotherapy. This represents a substantial increase in the time patients lived without disease progression.
The median duration of response (DoR), which measures how long patients continued to respond to treatment, was 6.2 months for those treated with HWK-016, MUCIN-16-targeted ADC, compared to 3.1 months for patients on standard chemotherapy. Furthermore, the median overall survival (OS) was 16.0 months for patients receiving HWK-016, MUCIN-16-targeted ADC, compared to 10.0 months for those on standard chemotherapy, indicating a longer overall lifespan for patients treated with HWK-016, MUCIN-16-targeted ADC.
Currently Recruiting Trials
Whitehawk Therapeutics, Inc. is currently recruiting participants for a clinical trial investigating HWK-016, an innovative MUCIN-16-targeted antibody-drug conjugate (ADC). This study aims to evaluate the safety and effectiveness of HWK-016 in patients with advanced solid tumors, including specific conditions like Platinum Resistant Ovarian Cancer (PROC) and Endometrial Cancer.
The study, identified as NCT07470853, is a first-in-human, multicenter, open-label Phase 1 trial. It is designed to enroll up to 265 adult participants. This study employs a dose escalation and dose expansion design, meaning researchers will gradually increase the dose to find the safest and most effective level, and then expand to more participants to gather further data. There is no control group in this study. Participants will receive HWK-016 in 21-day treatment cycles. The trial is structured into two main parts: Part A focuses on HWK-016 as a single agent, with several dose escalation and expansion groups for various tumor types. Part B explores HWK-016 in combination with Bevacizumab, also featuring its own dose escalation and expansion cohorts. This comprehensive approach allows for a thorough evaluation of HWK-016, both alone and in combination. Eligible participants must be 18 years of age, of any gender, and have advanced or metastatic solid tumors; healthy volunteers and children are not included in this study.
Where to Participate
Participation in the HWK-016 clinical trial is available across the United States, with 12 sites currently open in 11 states. This broad geographic reach aims to provide access to this investigational treatment for a diverse group of patients.
The top participating locations include:
- Little Rock, Arkansas
- Los Angeles, California
- Sarasota, Florida
- Peoria, Illinois
- Detroit, Michigan
- Lake Success, New York
- New York, New York
- Charlotte, North Carolina
- Columbus, Ohio
- Philadelphia, Pennsylvania
Development Timeline
The journey of HWK-016, an investigational MUCIN-16-targeted ADC, began with its initial development focus on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the understanding of HWK-016's potential evolved, leading its developer, Whitehawk Therapeutics, Inc., to expand its therapeutic focus.
This strategic shift led to the initiation of clinical trials targeting advanced solid tumors, specifically including Platinum Resistant Ovarian Cancer (PROC). The first clinical trial for HWK-016, NCT07470853, commenced on March 13, 2026. This landmark study represents the drug's entry into human trials, marking a significant milestone in its development. Currently, HWK-016 is in Phase 1 development, with this single trial enrolling up to 265 participants. This initial phase is crucial for evaluating the drug's safety, tolerability, and preliminary efficacy in patients with advanced cancers, paving the way for potential future studies in broader patient populations.