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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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