PROCPhase 1NCT07470853
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
A Phase 1 study testing HWK-016, MUCIN-16-targeted ADC and Bevacizumab in people with PROC and Platinum Resistant Ovarian Cancer, run by Whitehawk Therapeutics, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer
- What is being tested?
- HWK-016, MUCIN-16-targeted ADC and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Mar 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one of the following solid tumor cancers:
- Monotherapy escalation, backfill and expansion cohorts:
- Endometrial Carcinoma
- Ovarian Cancer
- Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Who cannot join
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
Show all 9Show fewer
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Central email mailbox - Whitehawk Therapeutics contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Not yet recruiting
Atrium Health - Wake Forest
Charlotte, North Carolina, 282204
Michelle Treadwell, 980-442-2000, michelle.treadwell@advocatehealth.org
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Anna Brantley, Sr. Clinical Research Nurse, 800-293-5066, anna.brantley@osumc.edu
David O'Malley, MD
- Recruiting
SCRI - Mary Crowley Cancer Research
Dallas, Texas, 75230
Reva Schneider, 972-566-3000, reva.schneider@scri.com
- Not yet recruiting
Karmanos Cancer Center
Detroit, Michigan, 48201
Clarice Zuccaro, 800-527-6266, zuccaroc@karmanos.org
- Recruiting
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Matthew Kovak, 501-296-1200, MRKovak@uams.edu
- Recruiting
Start - Ny
Long Island City, New York, 11042
Sadia Morium, Study Coordinator, 363-207-5160, sadia.morium@startresearch.com
Geraldine O'Sullivan-Coyne, MD
- Recruiting
START - Los Angeles
Los Angeles, California, 90025
Linda Rodriguez, 210-593-5250, linda.rodriguez@startresearch.com
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 07920
Taylor Nortman, 718-920-4321, nortnamt@mskcc.org
- Recruiting
St. Francis Medical Center (OSF Healthcare)
Peoria, Illinois, 61637
Lisa Gale, CRC RN, 309-655-3743, lisa.m.gale@osfhealthcare.org
Michelle Rowland, MD
- Recruiting
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
Ida Micaily, 215-955-1800, ida.micaily@jefferson.edu
- Recruiting
START Mountain
Salt Lake City, Utah, 84119
William McKean, MD, 801-907-4750
- Recruiting
SCRI - Florida Cancer Specialists
Sarasota, Florida, 34232
Bianca Reyes, 720-254-2610, bianca.reyes@mckesson.com
About this study
Official title: A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
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.
Read the detailed description
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.
- Conditions
- PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer
- Being tested
- HWK-016, MUCIN-16-targeted ADC, Bevacizumab
- Keywords
- Ovarian Cancer, Endometrial Cancer, PROC, Ovarian, Endometrial, ADC, Phase 1, Solid tumor
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HWK-016, MUCIN-16-targeted ADCDrug
Also called HWK-016
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
BevacizumabDrug
Bevacizumab administered according to the USPI in 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Part A - Dose Escalation - 21 Day treatment cycles | Experimental | Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) Receives: Drug: HWK-016, MUCIN-16-targeted ADC |
| Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD | Experimental | Dose Optimization of Recommended dose for expansion 1 Receives: Drug: HWK-016, MUCIN-16-targeted ADC |
| Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | Experimental | Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer Receives: Drug: HWK-016, MUCIN-16-targeted ADC |
| Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | Experimental | Expansion of enrolment at RDE 1 or 2 in Tumor TBD Receives: Drug: HWK-016, MUCIN-16-targeted ADC |
| 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 Receives: Drug: HWK-016, MUCIN-16-targeted ADC; Drug: Bevacizumab |
| Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | Experimental | Expansion of enrolment at RDE 1 or 2 in Tumor TBD Receives: Drug: HWK-016, MUCIN-16-targeted ADC |
| 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 Receives: Drug: HWK-016, MUCIN-16-targeted ADC; Drug: Bevacizumab |
| 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 Receives: Drug: HWK-016, MUCIN-16-targeted ADC; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.
Secondary outcomes (13)
Characterize the Volume of Distribution (Vd) of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Pharmacokinetic analysis of HWK-016 in human subjects
Measured: Cycle 1 and Cycle 4 (21-day cycles)
Maximum Concentration - Cmax of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Maximum amount of study drug and drug components in blood following infusion.
Measured: 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.
Measured: 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
Measured: 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
Measured: Cycle 1 and Cycle 4 - (21-day cycles)
Clearance (CL)
Measured rate at which HWK-016 is cleared from the blood following infusion.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation will use a BOIN design.
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whitehawk Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Catalyst Pharmaceutical Research
- Responsible party
- Sponsor
- Investigators
- Margaret C Dugan, MD, Study director, Whitehawk TherapeuticsAllison Uppalawanna, Study director, Whitehawk Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470853
- Sponsor's protocol ID
- HWK-016-101
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07470853
- Acronym / sponsor ID
- HWK-016-101
- Conditions
- PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer
- Keywords
- Ovarian Cancer, Endometrial Cancer, PROC, Ovarian, Endometrial, ADC, Phase 1, Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Whitehawk Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Catalyst Pharmaceutical Research
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Dose escalation will use a BOIN design.
| Arm | Type | Receives |
|---|---|---|
| Part A - Dose Escalation - 21 Day treatment cycles | Experimental | Drug: HWK-016, MUCIN-16-targeted ADCEscalating 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 | Drug: HWK-016, MUCIN-16-targeted ADCDose Optimization of Recommended dose for expansion 1 |
| Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-016, MUCIN-16-targeted ADCExpanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer |
| Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-016, MUCIN-16-targeted ADCExpansion 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 | Drug: HWK-016, MUCIN-16-targeted ADC, Drug: BevacizumabEscalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer |
| Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | Experimental | Drug: HWK-016, MUCIN-16-targeted ADCExpansion 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 | Drug: HWK-016, MUCIN-16-targeted ADC, Drug: BevacizumabExpanded 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 | Drug: HWK-016, MUCIN-16-targeted ADC, Drug: BevacizumabExpanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have one of the following solid tumor cancers:
Key exclusion criteria (9 listed)
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Any serious unresolved toxicities from prior therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HWK-016, MUCIN-16-targeted ADCAlso: HWK-016HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. | Drug | Part A - Dose Escalation - 21 Day treatment cycles, Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD, Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD, Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD, Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD, Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab, Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab, Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab |
| BevacizumabBevacizumab administered according to the USPI in 21-day cycles | Drug | Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab, Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab, Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab |
Primary outcome
Determine Maximum Tolerated Dose (MTD)
Time frame: From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
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
Determine Maximum Administered Dose (MAD)
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
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
Determine Recommended Dose For Expansion (RDE)
Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.
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.
13 secondary outcomes
Characterize the Volume of Distribution (Vd) of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Maximum Concentration - Cmax of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time frame: At Cycle 1 and Cycle 4 - (21-day cycles)
Time to Maximum Concentration (Tmax) of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 - (21-day cycles)
Area Under the Concentration Time Curve (AUC) for HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 - (21-day cycles
T1/2 - Half-life of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time frame: Cycle 1 and Cycle 4 - (21-day cycles)
Clearance (CL)
Time frame: Cycle 1 and Cycle 4 (21-day cycles)
Assess ADA (Anti drug antibody) against HWK-016
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: From Cycle 1, Day 1 (21-day cycles) until disease progression or 24 months, whichever comes first.
Evaluate Progression-free Survival (PFS)
Time frame: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months)
Evaluate Disease control Rate (DCR)
Time frame: From Cycle 1, Day 1 (21-day cycles) infusion to End of Study (up to 24 months
Time to Response (TTR)
Time frame: From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Central email mailbox - Whitehawk Therapeutics contact
Margaret C Dugan, MD study director
Whitehawk Therapeutics
Allison Uppalawanna study director
Whitehawk Therapeutics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HWK-016, MUCIN-16-targeted ADC and Bevacizumab in people with PROC and Platinum Resistant Ovarian Cancer, run by Whitehawk Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager Lead (866-742-9495, WHWK-Clinical-Trials@whitehawktx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Maximum Tolerated Dose (MTD) (time frame: From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.