A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWhitehawk Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Endometrial Carcinoma
Ovarian Cancer
Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
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-016, MUCIN-16-targeted ADC
DrugHWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.
Bevacizumab
DrugBevacizumab administered according to the USPI in 21-day cycles
Treatment groups
265 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Part A - Dose Escalation - 21 Day treatment cyclesExperimental treatment 1 intervention
Group B: Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group C: Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group D: Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group E: Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with BevacizumabExperimental treatment 2 interventions
Group F: Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBDExperimental treatment 1 intervention
Group G: Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with BevacizumabExperimental treatment 2 interventions
Group H: Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with BevacizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Determine Maximum Tolerated Dose (MTD)
Determine the highest dose of HWK-016 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). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
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 of HWK-016 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). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
Time frame
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.3
Determine Recommended Dose For Expansion (RDE)
Determine the dose of HWK-016 that will be recommended for further study within the tumor types studied in this clinical trial, measured at the end of Cycle 1, Day 21 (21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer.
Time frame
From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.Secondary outcomes
1
Characterize the Volume of Distribution (Vd) of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Pharmacokinetic analysis of HWK-016 in human subjects
Time frame
Cycle 1 and Cycle 4 (21-day cycles)2
Maximum Concentration - Cmax of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Maximum amount of study drug and drug components in blood following infusion.
Time frame
At Cycle 1 and Cycle 4 - (21-day cycles)3
Time to Maximum Concentration (Tmax) of HWK-016 (ADC, total antibody, CPT116, and CPT119)
Time to reach maximum concentration of drug and drug components in blood following infusion.
Time frame
Cycle 1 and Cycle 4 - (21-day cycles)4
Area Under the Concentration Time Curve (AUC) for HWK-016 (ADC, total antibody, CPT116, and CPT119)
The total area under the concentration time curve of study drug and drug components following infusion
Time frame
Cycle 1 and Cycle 4 - (21-day cyclesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Whitehawk Therapeutics, Inc.
Lead sponsor
Catalyst Pharmaceutical Research
Collaborator
Source ClinicalTrials.gov