Status:
UNKNOWN
Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identif...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03398720
Start Date
December 31 2017
End Date
December 31 2019
Last Update
January 12 2018
Active Locations (3)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, United States, 37203
3
MD Anderson Cancer Center
Houston, Texas, United States, 77230