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Recruiting NCT07470853

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

Phase I Interventional PROC Platinum Resistant Ovarian Cancer Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HWK-016, MUCIN-16-targeted ADC, Bevacizumab.
Who it may be relevant to
Registry conditions: PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Drug Bevacizumab
    Bevacizumab administered according to the USPI in 21-day cycles

Primary outcome measures

  • Determine Maximum Tolerated Dose (MTD) [Time frame: 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 Recommended Dose For Expansion (RDE) [Time frame: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • University of Arkansas - Winthrop P. Rockefeller Cancer Institute — Little Rock
  • START - Los Angeles — Los Angeles
  • SCRI - Florida Cancer Specialists — Sarasota
  • St. Francis Medical Center (OSF Healthcare) — Peoria
  • Karmanos Cancer Center — Detroit
  • Start - Ny — Lake Success
  • Memorial Sloan Kettering Cancer Center — New York
  • Atrium Health - Wake Forest — Charlotte
  • … and 4 more centers

Identifiers

NCT: NCT07470853 · HWK-016-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗