A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

March 9, 2026 updated by: Whitehawk Therapeutics, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

265

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • University of Arkansas - Winthrop P. Rockefeller Cancer Institute
        • Contact:
    • California
      • Los Angeles, California, United States, 90025
    • Florida
      • Sarasota, Florida, United States, 34232
        • Not yet recruiting
        • SCRI - Florida Cancer Specialists
        • Contact:
    • Illinois
      • Peoria, Illinois, United States, 61637
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Karmanos Cancer Center
        • Contact:
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Start - Ny
        • Contact:
          • Geraldine O'Sullivan-Coyne, MD
          • Phone Number: 363-207-5160
      • New York, New York, United States, 07920
        • Not yet recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 282204
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • SCRI - Sydney Kimmel Cancer Center - Jefferson Health
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
        • Not yet recruiting
        • SCRI - Mary Crowley Cancer Research
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84119
        • Recruiting
        • START Mountain
        • Contact:
          • William McKean, MD
          • Phone Number: 801-907-4750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - Dose Escalation - 21 Day treatment cycles
Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Experimental: Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD
Dose Optimization of Recommended dose for expansion 1
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Experimental: Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD
Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Experimental: Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD
Expansion of enrolment at RDE 1 or 2 in Tumor TBD
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Experimental: Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab
Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Drug: Bevacizumab
Bevacizumab administered according to the USPI in 21-day cycles
Experimental: Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD
Expansion of enrolment at RDE 1 or 2 in Tumor TBD
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Experimental: Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab
Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Drug: Bevacizumab
Bevacizumab administered according to the USPI in 21-day cycles
Experimental: Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab
Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD
Drug: HWK-016, MUCIN-16-targeted ADC
HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Other Names:
  • HWK-016
Drug: Bevacizumab
Bevacizumab administered according to the USPI in 21-day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
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
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
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.
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pharmacokinetic analysis of HWK-016 in human subjects
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)
Maximum amount of study drug and drug components in blood following infusion.
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)
Time to reach maximum concentration of drug and drug components in blood following infusion.
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
The total area under the concentration time curve of study drug and drug components following infusion
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)
Time for 1/2 of the infused drug to be eliminated/metabolized
Cycle 1 and Cycle 4 - (21-day cycles)
Clearance (CL)
Time Frame: Cycle 1 and Cycle 4 (21-day cycles)
Measured rate at which HWK-016 is cleared from the blood following infusion.
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.
Using a blood test, determine the risk of developing anti-drug antibodies against HWK-016 following infusion in human patients.
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.
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
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.
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
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.
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
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)
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
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
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
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
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
From Cycle 1, Day 1 (21-day cycles) until End of Study or 24 months, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Whitehawk Therapeutics, Inc.

Collaborators

Catalyst Pharmaceutical Research

Investigators

  • Study Director: Margaret C Dugan, MD, Whitehawk Therapeutics
  • Study Director: Edward Spindler, BS, MBA, Whitehawk Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HWK-016-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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