Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
1 other identifier
interventional
100
1 country
3
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 with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2017
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2017
CompletedStudy Start
First participant enrolled
December 31, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 12, 2018
January 1, 2018
1 year
December 26, 2017
January 6, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse events
Number of participants with AEs and SAEs
Up to 2 year
Dose-limiting toxicity (DLT)
Number of participants with DLTs
Up to 2 years
Secondary Outcomes (5)
AUC
Up to 1 year
Cmax
Up to 1 year
Anti-drug antibodies
Up to 2 year
Objective response rate
Up to 2 years
Progression-free survival (PFS)
Up to 2 years
Study Arms (4)
Cohort 1
EXPERIMENTALOne participant will receive HTI-1066 at the starting dose.
Cohort 2
EXPERIMENTALParticipants will receive HTI-1066 at dose level 2.
Cohort 3
EXPERIMENTALParticipants will receive HTI-1066 at dose level 3.
Cohort 4
EXPERIMENTALParticipants will receive HTI-1066 at dose level 4.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77230, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 12, 2018
Study Start
December 31, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
January 12, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share