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

ConditionsEndometrial CancerOvarian CancerOvarian Cancer MetastaticOvarian Cancer Metastatic RecurrentNon-squamous EGFR Wt NSCLCPlatinum Resistant Ovarian CancerPROC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWhitehawk Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

non-squamous EGFR-Wt NSCLC

Endometrial carcinoma

Platinum Resistant Ovarian Cancer

Non-squamous EGFR-Wt NSCLC

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • HWK-007

    Drug

    HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.

Treatment groups

226 Participants
are divided into 5 treatment groups
Group A: Dose Escalation - 21 Day treatment cycleExperimental treatment 1 intervention
Group B: Dose Expansion Group 1- 21-day treatment cycle - non-squamous EGFR-WT NSCLCExperimental treatment 1 intervention
Group C: Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group D: Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group E: Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine Maximum Tolerated Dose (MTD)

Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

Time frame
From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
2

Determine Maximum Administered Dose (MAD)

Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

Time frame
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
3

Determine the Recommended Dose for Expansion (RDE)

Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

Time frame
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.

Secondary outcomes

1

Characterize the Volume of Distribution (Vd) of HWK-007 (ADC, total antibody, CPT116, and CPT119)

Pharmacokinetic analysis of HWK-007 in human subjects

Time frame
Cycle 1 and Cycle 4 (21-day cycles)
2

Assess ADA (Anti drug antibody) against HWK-007

Using a blood test, determine the risk of developing anti-drug antibodies against HWK-007 following infusion in human patients.

Time frame
Every cycle from Cycle 1, Day 1 (21-day cycles) until 30 days past the last dose of study drug for up to 24 months.
3

Evaluate the Overall Response Rate (ORR)

Measure the response rate to the study drug by CT-scans evaluated using RECIST1.1

Time frame
From Cycle 1, Day 1 (21-day cycles), every 6-weeks for the first 4 assessments and then every 6 weeks for up to 24 months until disease progression or 24 months, whichever comes first.
4

Evaluate Overall Survival (OS).

Measure how long patient lives following treatment with HWK-007

Time frame
From Cycle 1, Day 1 (21-day cycles) until death or 24 months, whichever comes first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Whitehawk Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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