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

a study on PROC Ovarian Cancer Endometrial Cancer Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

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

Details

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.

Keywords

PROC, Platinum Resistant Ovarian Cancer, Endometrial Cancer, Ovarian Cancer, Ovarian, Endometrial, ADC, Phase 1, Solid tumor, Endometrial Neoplasms, Ovarian Neoplasms, Bevacizumab, HWK-016, MUCIN-16-targeted ADC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  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

Locations

  • START - Los Angeles accepting new patients
    Los Angeles California 90025 United States
  • START Mountain accepting new patients
    Salt Lake City Utah 84119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Whitehawk Therapeutics, Inc.
Links
Sign up for this study
ID
NCT07470853
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 265 study participants
Last Updated
Contact us about this trial