HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours

NCT04914351 | Completed Phase 1 FDA Drug

• 1 other identifier: HY-0102-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase I, first-in-human trial to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors.

Conditions

Locally Advanced/Metastatic Solid Tumors

Keywords

HY-0102, solid tumors

Outcome Measures

Primary Outcomes (6)

• Occurrence of Drug Limited Toxicities (DLTs)

  To assess by the occurrence of Drug Limited Toxicities (DLTs)

  From Time of First dose through DLT observation period, 28 days

• Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs).

  To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

  From the start of treatment until up to 90 days after the last dose of study drug

• Number of patients with changes in laboratory parameters from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of patients with changes in electrocariogram (ECG) from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of participants with changes in left ventricular ejection fraction (LVEF) from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

• Number of participants with changes in Clinically Significant Vital Sign from baseline

  To assess safety of HY-0102

  From the start of treatment until up to 30(±7) days after the last dose of study drug

Secondary Outcomes (15)

• Cmax (Maximum observed serum concentration) of HY-0102

  From first dose through 30days(±7) days after the last dose of study medication

• Ctrough (Trough observed serum concentration) of HY-0102

  From first dose through 30(±7) days after the last dose of study medication

• Tmax (Time of maximum observed serum concentration) of HY-0102

  From first dose through 30(±7) days after the last dose of study medication

• AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of HY-0102

  From first dose through 30(±7) days after the last dose of study medication

• AUC(tau) [Area under the concentration-time curve in one dosing interval] of HY-0102

  From first dose through 30(±7) days after the last dose of study medication

Other Outcomes (1)

• Biomarkers

  From first dose through 30(±7) days after the last dose of study medication

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Cohort 1: 0.03 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 2: 0.3 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Accelerated dose escalation: One patient will be enrolled. Cohort 3: 1 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 4: 2 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 5: 4 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort. Cohort 6: 10 mg/kg Q2W HY-0102 ivgtt Duration: 26w DLT observation period: 28 days Standard 3+3 Dose escalation: Three patients will be enrolled for each dose cohort.

Drug: HY-0102

Interventions

HY-0102 DRUG

Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years
• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
• Histologically or cytologically confirmed incurable, unresectable, locally advanced or metastatic cancer that is refractory to standard therapies.
• Prior Therapy
• Have progressed on or are intolerant to all standard therapies
• Have no available therapies known to confer clinical benefit
• Measurable or evaluable disease per RECIST v1.1 Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam.
• ECOG performance status 0 or 1; Life expectancy ≥ 3 months.
• Adequate hepatic function as evidenced by meeting all the following requirements:
• Total bilirubin ≤ 1.5 ×within institutional upper limit of normal (ULN); or ≤ 2.5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome or familial benign.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; AST or ALT ≤ 5 × ULN if liver metastases are present.
• Serum creatinine \< 1.5 × ULN and calculated creatinine clearance (CrCL) \> 30 mL/min (Cockroft-Gault Equation).
• Hematological function defined as:
• Absolute neutrophil count ≥ 1,500//L without growth factor support in the 2 weeks prior to study entry
• Hemoglobin \> 9 g/dL without transfusion in the 2 weeks prior to study entry

You may not qualify if:

• Symptomatic central nervous system metastases. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy, and are on a stable or decreasing dose of corticosteroids are eligible for study entry.
• Uncontrolled hypertension (systolic blood pressure \>150 mmHg and diastolic blood pressure \>90 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
• Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry.
• QTc \> 450 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome \[consider QTc \< 480 rather than 450\]
• Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or \< T1 urothelial carcinoma.
• Active infection requiring intravenous therapy within 2 weeks prior to entry.
• Active HIV, hepatitis B or hepatitis C virus. or
• Patients infected with the HIV virus will be eligible if their CD4 count is \> 350 cells/mm3 and the patient is on anti-retroviral therapy with an HIV viral load that is below the level of detection.
• Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer \< 1000 cps/mL or 200 IU/mL), or cured Hepatitis C (negative HCV RNA test) may be enrolled. For patients with hepatocellular carcinoma, patient with chronic infections with hepatitis C virus (treated or untreated); and patients with hepatitis B virus who were treated with antiviral therapy and who had a HBV viral load less than 200 IU/mL may also be enrolled.
• Active tuberculosis
• Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; Palliative radiotherapy to a single area of metastasis is within 2 weeks prior to study entry.
• Prior treatment with drugs in the same class.
• Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry.
• Allergy to study drug or components of its formulation.
• No history of a Grade 3-4 allergic reaction to treatment with another monoclonal antibody.

Sponsors & Collaborators

• Shanghai HyaMab Biotech Co.,Ltd.: lead

Study Sites (3)

Sarah Cannon Research Institute

Orlando, Florida, 32827, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89119, United States

Location

Texas Oncology

Tyler, Texas, 75702, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase I, first-in-human, single-arm and multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 in adult patients with locally advanced/metastatic malignant solid tumors.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: May 3, 2022
• Primary Completion: November 27, 2023
• Study Completion: December 30, 2023
• Last Updated: March 13, 2024

Record last verified: 2023-04

Locations

US (3)