Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors

Status unconfirmed · Phase 1

Conditions studied: Solid Tumor, Adult

In brief

HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.

Key facts

Study ID

NCT03398720

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

100

Starts

2017-12-31

Expected to finish

2019-12-31

Last updated by the study team

2018-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥18 years of age
• Subject must have an advanced solid tumor
• ECOG Performance Status of 0 or 1
• Life expectancy ≥12 weeks
• Adequate laboratory parameters
• Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if…

• Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
• Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
• Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
• Any other prohibited or restricted medication as described in the study protocol.
• Investigational therapy administered <5 half-lives before the first dose of HTI-1066
• Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.
• Active CNS metastases.
• Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
• History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
• History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)
• Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
• Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.
• Unresolved toxicities from previous anticancer therapy.

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States (enrolling)
• Sarah Cannon - Tennessee Oncology — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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