NCT07470853 A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
| NCT ID | NCT07470853 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Whitehawk Therapeutics, Inc. |
| Condition | PROC |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2026-03-15 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 265 participants in total. It began in 2026-03-15 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Have one of the following solid tumor cancers: 1. Monotherapy escalation, backfill and expansion cohorts: 1. Endometrial Carcinoma 2. Ovarian Cancer 2. Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer Exclusion Criteria: 1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases 2. Individual with history of carcinomatous meningitis 3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection 4. Individual with evidence of corneal keratopathy or history of cornea transplant 5. Any serious unresolved toxicities from prior therapy 6. Significant cardiovascular disease 7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms) 8. History of pneumonitis/interstitial lung disease 9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Contact & Investigator
Margaret C Dugan, MD
STUDY DIRECTOR
Whitehawk Therapeutics
Frequently Asked Questions
Who can join the NCT07470853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PROC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07470853 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07470853 currently recruiting?
Yes, NCT07470853 is actively recruiting participants. Contact the research team at WHWK-Clinical-Trials@whitehawktx.com for enrollment information.
Where is the NCT07470853 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Sarasota, United States, Peoria, United States and 8 additional locations.
Who is sponsoring the NCT07470853 clinical trial?
NCT07470853 is sponsored by Whitehawk Therapeutics, Inc.. The principal investigator is Margaret C Dugan, MD at Whitehawk Therapeutics. The trial plans to enroll 265 participants.