Clinical trial · Interventional
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Platinum Resistant Ovarian Cancer | Platinum-Resistant Ovarian Carcinoma | ALIAS | 0.90 |
| PROC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| HWK-016, MUCIN-16-targeted ADC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Part A - Dose Escalation - 21 Day treatment cycles
- description
- Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV)
- interventionNames
- Drug: HWK-016, MUCIN-16-targeted ADC
- type
- EXPERIMENTAL
- label
- Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD
- description
- Dose Optimization of Recommended dose for expansion 1
- interventionNames
- Drug: HWK-016, MUCIN-16-targeted ADC
- type
- EXPERIMENTAL
- label
- Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
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 interventionReferences
Publications (0)
Data not yet available