NCT07470853

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

PROCPlatinum Resistant Ovarian CancerEndometrial Cancer

Keywords

Ovarian CancerEndometrial CancerPROCOvarianEndometrialADCPhase 1Solid tumor

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    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)

    Cycle 1 and Cycle 4 (21-day cycles)

  • Maximum Concentration - Cmax of HWK-016 (ADC, total antibody, CPT116, and CPT119)

    At Cycle 1 and Cycle 4 - (21-day cycles)

  • Time to Maximum Concentration (Tmax) of HWK-016 (ADC, total antibody, CPT116, and CPT119)

    Cycle 1 and Cycle 4 - (21-day cycles)

  • Area Under the Concentration Time Curve (AUC) for HWK-016 (ADC, total antibody, CPT116, and CPT119)

    Cycle 1 and Cycle 4 - (21-day cycles

  • T1/2 - Half-life of HWK-016 (ADC, total antibody, CPT116, and CPT119)

    Cycle 1 and Cycle 4 - (21-day cycles)

  • +8 more secondary outcomes

Study Arms (8)

Part A - Dose Escalation - 21 Day treatment cycles

EXPERIMENTAL

Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)

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

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

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

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

Drug: HWK-016, MUCIN-16-targeted ADCDrug: 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

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

Drug: HWK-016, MUCIN-16-targeted ADCDrug: 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

Drug: HWK-016, MUCIN-16-targeted ADCDrug: Bevacizumab

Interventions

HWK-016, MUCIN-16-targeted ADCDRUG

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

Also known as: HWK-016
Part A - Dose Escalation - 21 Day treatment cyclesPart A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBDPart A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBDPart A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBDPart A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBDPart B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with BevacizumabPart B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with BevacizumabPart B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab
BevacizumabDRUG

Bevacizumab administered according to the USPI in 21-day cycles

Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with BevacizumabPart B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with BevacizumabPart B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Arkansas - Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205, United States

NOT YET RECRUITING

START - Los Angeles

Los Angeles, California, 90025, United States

RECRUITING

SCRI - Florida Cancer Specialists

Sarasota, Florida, 34232, United States

NOT YET RECRUITING

St. Francis Medical Center (OSF Healthcare)

Peoria, Illinois, 61637, United States

NOT YET RECRUITING

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Start - Ny

Lake Success, New York, 11042, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 07920, United States

NOT YET RECRUITING

Atrium Health - Wake Forest

Charlotte, North Carolina, 282204, United States

NOT YET RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

SCRI - Sydney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

SCRI - Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

NOT YET RECRUITING

START Mountain

Salt Lake City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Margaret C Dugan, MD

    Whitehawk Therapeutics

    STUDY DIRECTOR

  • Edward Spindler, BS, MBA

    Whitehawk Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Clinical Trial Manager Lead

CONTACT

888-392-9025WHWK-Clinical-Trials@whitehawktx.com

Central email mailbox - Whitehawk Therapeutics

CONTACT

WHWK-Clinical-Trials@whitehawktx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation will use a BOIN design.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

US(12)