Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors

Whitehawk Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: PROC; Endometrial Cancer; Non-squamous EGFR Wt NSCLC; Ovarian Cancer Metastatic Recurrent; Ovarian Cancer; Platinum Resistant Ovarian Cancer; Ovarian Cancer Metastatic

Treatments: Drug: HWK-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT07444814

HWK-007-101

Details and patient eligibility

About

HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.

Full description

The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a.

In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Enrollment: 226 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 and backfill cohorts:

   1. non-squamous EGFR-Wt NSCLC
   2. Endometrial carcinoma
   3. Platinum Resistant Ovarian Cancer

2. Monotherapy expansion cohorts:

   1. Non-squamous EGFR-Wt NSCLC
   2. Additional tumor indications to be defined in a future amendment

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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226 participants in 5 patient groups

Dose Escalation - 21 Day treatment cycle

Experimental group

Description:

Escalating doses of HWK-007 administered intravenously (IV)

Treatment:

Drug: HWK-007

Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLC

Experimental group

Description:

Expanded enrolment at selected dose of HWK-007 in NSCLC.

Treatment:

Drug: HWK-007

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

Experimental group

Description:

Expanded enrolment at second selected dose of HWK-007 administered intravenously (IV) in Tumor - TBD

Treatment:

Drug: HWK-007

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

Experimental group

Description:

Expanded enrolment at third selected dose in Tumor - TBD

Treatment:

Drug: HWK-007

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

Experimental group

Description:

Dose Expansion of HWK-007, a PTK7-directed ADC.

Treatment:

Drug: HWK-007