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NCT Number: NCT07470853

A 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.

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Key information

Conditions

PROC Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Platinum Resistant Ovarian Cancer Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas - Winthrop P. Rockefeller Cancer Institute, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

HWK-016, MUCIN-16-targeted ADC

Drug

HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.

Other names: HWK-016

Bevacizumab

Drug

Bevacizumab administered according to the USPI in 21-day cycles

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Central email mailbox - Whitehawk Therapeutics

CONTACT

[email protected]

Clinical Trial Manager Lead

CONTACT

[email protected]

888-392-9025

Sponsors and collaborators

Lead sponsor

Whitehawk Therapeutics, Inc.

Industry

Collaborators

  • Catalyst Pharmaceutical Research

Registry information

Official study title

A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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