HWK-016 for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HWK-016, targeting ovarian and endometrial cancers. The goal is to determine if HWK-016, alone or with another drug called bevacizumab, is safe and effective for individuals with advanced cancer. Researchers adjust the dose during different trial phases to find the optimal one. Those with advanced ovarian or endometrial cancer might find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, HWK-016, a special type of treatment, proved very effective in treating solid tumors. Since HWK-016 is being tested in humans for the first time, detailed safety information from people is not yet available. The study is currently in Phase 1, focusing on assessing the treatment's safety and tolerability.
Phase 1 studies generally aim to find the safest dose and identify any side effects. The progression to Phase 1 indicates that HWK-016 showed some safety promise in earlier lab tests before human trials.
Additionally, HWK-016 is being tested alone and in combination with another drug, bevacizumab, which has been used in other treatments and is usually well-tolerated. This combination might enhance treatment effects while maintaining safety, but more information from human studies is needed to confirm this. As this is an early-stage trial, the main goal is to ensure the treatment's safety and determine the best dose for future studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about HWK-016 for ovarian cancer because it targets the MUCIN-16 protein, which is overexpressed in many ovarian tumors. Unlike standard treatments like chemotherapy, which can affect both cancerous and healthy cells, HWK-016 is an antibody-drug conjugate (ADC) that delivers a cytotoxic agent directly to the cancer cells, potentially reducing side effects. Additionally, some trial arms are exploring HWK-016 in combination with Bevacizumab, a drug that inhibits tumor blood vessel growth, potentially enhancing the overall treatment effectiveness. This targeted approach offers a new hope for more efficient and less harmful ovarian cancer treatment.
What evidence suggests that HWK-016 could be an effective treatment for ovarian cancer?
Research has shown that HWK-016 targets a protein called MUCIN-16, which appears in large amounts in ovarian cancer cells. Studies indicate that MUCIN-16 is much more prevalent in ovarian cancer than in other conditions, making it a promising treatment target. Early lab tests demonstrated that HWK-016 can specifically attach to cancer cells and shrink tumors, even at low doses. In this trial, some participants will receive HWK-016 alone, while others will receive it in combination with Bevacizumab, a drug known to enhance treatment effects in ovarian cancer. This combination holds promise for even better results. While these findings are encouraging, further research is needed to confirm HWK-016's effectiveness in people.12367
Who Is on the Research Team?
Allison Uppalawanna
Principal Investigator
Whitehawk Therapeutics
Margaret C Dugan, MD
Principal Investigator
Whitehawk Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic ovarian or endometrial cancer. People can't join if they are pregnant, breastfeeding, have uncontrolled brain tumors, serious eye problems, active infections, certain lung diseases, heart issues, or unresolved side effects from previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of HWK-016, a MUCIN-16-targeted ADC, administered intravenously in 21-day treatment cycles to determine the Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD).
Dose Expansion
Participants receive the Recommended Dose for Expansion (RDE) of HWK-016, either as monotherapy or in combination with Bevacizumab, to evaluate safety and preliminary antitumor activity.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pharmacokinetic analysis and evaluation of overall response rate, progression-free survival, and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- HWK-016
Trial Overview
The study tests a new targeted drug called HWK-016 (alone and with bevacizumab) in people with advanced solid tumors. It aims to find the best dose and see how safe it is. There is no control group; all participants receive the study drugs.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD
Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
Expansion of enrolment at RDE 1 or 2 in Tumor TBD
Expansion of enrolment at RDE 1 or 2 in Tumor TBD
Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer
Dose Optimization of Recommended dose for expansion 1
Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Whitehawk Therapeutics, Inc.
Lead Sponsor
Catalyst Pharmaceutical Research
Industry Sponsor
Citations
NCT07470853 | A Study of MUC16-Directed Antibody Drug ...
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. Other Names: HWK-016.
Whitehawk Therapeutics Presents Real-World Analysis ...
MUC16 is the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets.
3.
aacrjournals.org
aacrjournals.org/cancerres/article/86/7_Supplement/1324/776951/Abstract-1324-Preclinical-assessment-of-HWK-016-aAbstract 1324: Preclinical assessment of HWK-016, a next ...
The mechanism of action of HWK-016 was investigated in preclinical cancer models. Results showed that HWK-016 bound specifically to cell ...
Whitehawk Therapeutics Presents Real-World Analysis ...
HWK-016 is currently being evaluated in a Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers [NCT07470853].
5.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/whitehawk-therapeutics-presents-comprehensive-preclinical-220000329.htmlWhitehawk Therapeutics Presents Comprehensive ...
Exhibits bystander activity and produces tumor regressions at doses as low as 1 mg/kg in small cell lung cancer and ovarian cancer models.
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-muc16-directed-antibody-drug-conjugate-hwk-016-in-participants-with-advanced-solid-tumorsA Study of MUC16-Directed Antibody Drug Conjugate HWK ...
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 ...
Whitehawk Therapeutics Presents Comprehensive ...
HWK‑016 targets the non‑shed extracellular domain of MUC16 to avoid binding to circulating CA125 and associated antigen sink effects observed ...
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