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

Whitehawk Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Endometrial Cancer; PROC; Platinum Resistant Ovarian Cancer

Treatments: Drug: HWK-016, MUCIN-16-targeted ADC; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07470853

HWK-016-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 intervention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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265 participants in 8 patient groups

Part A - Dose Escalation - 21 Day treatment cycles

Experimental group

Description:

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

Treatment:

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

Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD

Experimental group

Description:

Dose Optimization of Recommended dose for expansion 1

Treatment:

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

Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD

Experimental group

Description:

Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer

Treatment:

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

Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD

Experimental group

Description:

Expansion of enrolment at RDE 1 or 2 in Tumor TBD

Treatment:

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

Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab

Experimental group

Description:

Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer

Treatment:

Drug: Bevacizumab

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

Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD

Experimental group

Description:

Expansion of enrolment at RDE 1 or 2 in Tumor TBD

Treatment:

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

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

Experimental group

Description:

Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer

Treatment:

Drug: Bevacizumab

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

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

Experimental group

Description:

Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD

Treatment:

Drug: Bevacizumab

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