A Phase I/II Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of HB0028 in Patients With Advanced Solid Tumors

Shanghai Huaota Biopharmaceutical Co., Ltd.1 site in 1 country54 target enrollmentSeptember 9, 2022

ConditionsAdvanced Solid Tumor Cervical Cancer

InterventionsHB0028

DrugsHB0028

Overview

Phase: Phase 1
Intervention: HB0028
Conditions: Advanced Solid Tumor
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Enrollment: 54
Locations: 1
Primary Endpoint: Safety and tolerability
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is a phase I/II open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of HB0028 in patients with advanced solid tumors.

Detailed Description

This is a phase I/II, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase I study, the safety and tolerability of HB0028 will be evaluated in patients with advanced solid tumors. In the phase II study, the safety and efficacy of HB0028 at the RP2D will be evaluated in cohorts of patients with specific solid tumors.

Registry

clinicaltrials.gov

Start Date

September 9, 2022

End Date

October 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all the following criteria to be eligible for participation in this study:
•Male or female. Age ≥ 18 years.
•The subject is able to understand and willing to sign the Informed Consent Form(ICF); willing and able to comply with all study procedures.
•a) dose escalation: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; \[These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.\].
•b) dose expansion (Cervical cancer group): Histologically confirmed persistent, recurrent, or metastatic (\[International Federation of Gynecology and Obstetrics(FIGO)\] stage IVB) cervical cancer that is not eligible for curative surgery and/or definitive concurrent radiotherapy; The pathological type was squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.; According to the investigator's judgment, it may benefit from the study drug treatment; patients with disease progression after at least one previous systemic therapy (such as systemic chemotherapy).
•At least one measurable tumor lesion was present according to RECIST 1.
•A baseline imaging assessment could be performed up to 28 days before the first dose.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-
•Life expectancy ≥12 weeks
•liver function requirements:

Exclusion Criteria

•Exclusion Criteria Patients are excluded from the study if any of the following criteria apply:
•Have clinically active central nervous system (CNS) metastases. Patients with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable (\>4 weeks) and asymptomatic. Patients with asymptomatic brain metastasis or subjects who are symptomatically stable after treatment and are on \< 10 mg/d prednisone or equivalent are eligible.
•dose expansion (Cervical cancer group): Hydronephrosis, which could not be relieved by clinical treatment
•Active autoimmune disease or history of autoimmune disease requiring systemic therapy \< 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
•History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).
•Use of systemic corticosteroids in a dose equivalent to \>10 mg/day of prednisone or other immunosuppressive agent \< 2 weeks prior to screening; the use of topical, intraocular, intraarticular, intranasal, or inhaled corticosteroids and systemic steroids to prevent (e.g., allergy to contrast agents) or treat non-autoimmune condition (e.g., delayed hypersensitivity caused by exposure to allergens) or short course (\< 5 days) will be allowed
•Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure \< 6 months of study entry; uncontrolled arrhythmia \< 3 months of study entry; mean ECG QT-interval corrected according to Fridericia's formula (QTcF) \> 470 milliseconds (ms) obtained from three ECGs;
•uncontrolled diabetes, glycosylated hemoglobin HbA1c \>8%；
•Anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; palliative radiotherapy to a single area \< 2 weeks prior to study screening is permitted. Measurable lesions cannot be previously irradiated unless they have demonstrated growth after radiation therapy (According to RECIST v1.1).
•Patients who have previously received allogeneic stem cell, Bone marrow or solid organ transplantation.

Arms & Interventions

HB0028

HB0028 IV every 3 weeks (q3w)

Intervention: HB0028

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: Up to 12 Months

Number of participants with a Dose Limiting Toxicity(DLT)\[Time Frame:During the first days\]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria,and assessed as having a suspected or definite relationship to study drug.

Maximun Tolerated Dose(MTD)

Time Frame: Up to 24 Months

MTD or Optimal Biological Dose(OBD) and/or RP2D.