A Study of of HOT1030 in Patients With Advanced Solid Tumors

NCT05060263 | Unknown Phase 1

• 1 other identifier: HOT-1030-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as measured by incidence of AEs (Adverse Events)

  Incidence and severity of AEs, Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

  through study completion， an average of 1 year

Secondary Outcomes (3)

• Area Under Curve (AUC) of HOT-1030

  42 days

• Maximum Serum Concentration (Cmax) of HOT-1030

  42 days

• Antitumor Activity of HOT-1030 in Patients With advanced Solid Tumors

  through study completion， an average of 1 year

Study Arms (7)

Cohort 1

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 2

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 3

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 4

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 5

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 6

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Cohort 7

EXPERIMENTAL

HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.

Drug: HOT-1030

Interventions

HOT-1030 DRUG

HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection

Also known as: no other interventions

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female from 18 to 75 yrs (include 18 yrs and 75 yrs).
• 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.
• Patients with histologically or cytologically confirmed advanced malignant solid tumor who have received or been intolerant of all standard therapies thought to confer clinical benefit.
• Measurable disease on imaging base on RECIST v1.1 for solid tumors;
• Stop anticancer therapy for more than 5 half-lives or 4 weeks (whichever is shorter) prior to study entry;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate organ function, as indicated by the laboratory values.
• Female patients of childbearing potential must have a negative serum pregnancy test at screening; Male patients and the female patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the Screening Visit through 90 days after the last dose of study treatment is received.
• Life expectancy \>3 months.

You may not qualify if:

• Received any anti-CD137 antibodies.
• Active primary CNS tumor or metastatic CNS tumor (expect the patients who had received the treatment and stopped the treatment for more than 4 weeks before first dose), active epilepsy, Spinal cord compression or Cancerous meningitis.
• 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.
• Require systematic anti-infective therapy a week before first dose because of active infection.
• Taken the surgical operations not related to the research 4 weeks before first dose
• Used of systemic corticosteroids (a dose equivalent \> 10 mg/day of prednisone or )or other immunosuppressive agents, excepted:
• Patients are allowed to have topical use or inhaled glucocorticoid.
• Patients are allowed to have a less than seven-day glucocorticoid treatment preventing or treat non-autoimmune allergic diseases.
• The toxicity of previous anti-tumor therapy has not recovered (defined as not recovering to grade 0 or 1, except for alopecia) or has not fully recovered from previous surgery.
• During the 6 months prior to screening, the patient had a history of major cardiovascular and cerebrovascular events, such as myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, unstable arrhythmias, unstable angina, transient ischemic attack, or cerebrovascular accidents.
• New York Heart Association (NYHA) grade III or IV congestive heart failure.
• Patients with uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg at the time of screening) who had been on a stable dose of antihypertensive drugs for at least 4 weeks at the time of screening).
• Active hepatitis B (hepatitis B virus titer \>103 copies /ml or 200IU/ml); Hepatitis C virus infection (HCV-RNA above the detection limit); Prophylaxis antiviral therapy other than interferon is allowed. In patients with advanced liver cancer (HCC), hepatitis B virus titer \>104 copies /ml or 2000IU/ml should be excluded.
• A history of known congenital and acquired immunodeficiency, including positive HIV antibody tests.
• Patients with a known history of severe allergic reactions to macromolecular protein formulations/monoclonal antibodies or to any investigational drug component (CTCAE V5.0 grade greater than 3).

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

Shanghai Huaota Biopharmaceutical Co., Ltd.

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Han Baohui, Doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yang yongming, Doctor

CONTACT

18964167352; yongmin.yang@huaota.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: dose-escalation study

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: September 29, 2021
• Study Start: March 12, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)