265 Participants NeededMy employer runs this trial

HWK-016 for Ovarian Cancer

Recruiting at 12 trial locations
CT
Ce
Overseen ByCentral email mailbox - Whitehawk Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Whitehawk Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

AU

Allison Uppalawanna

Principal Investigator

Whitehawk Therapeutics

MC

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

I have endometrial carcinoma or ovarian cancer.
I have been diagnosed with ovarian cancer.

Exclusion Criteria

Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
I have brain metastases that are not controlled.
I have corneal disease or have had a cornea transplant.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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).

21 days per cycle

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.

21 days per cycle

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.

Up to 24 months

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

Group I: Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with BevacizumabExperimental Treatment2 Interventions
Group II: Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with BevacizumabExperimental Treatment2 Interventions
Group III: Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with BevacizumabExperimental Treatment2 Interventions
Group IV: Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group V: Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group VI: Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group VII: Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBDExperimental Treatment1 Intervention
Group VIII: Part A - Dose Escalation - 21 Day treatment cyclesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Whitehawk Therapeutics, Inc.

Lead Sponsor

Catalyst Pharmaceutical Research

Industry Sponsor

Trials
2
Recruited
4,600+

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.

Abstract 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].

Whitehawk 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.

A 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 ...