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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398720
Recruitment Status : Unknown
Verified January 2018 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: HTI-1066 dose level 1 Drug: HTI-1066 dose level 2 Drug: HTI-1066 dose level 3 Drug: HTI-1066 dose level 4 Phase 1

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 identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 31, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Cohort 1
One participant will receive HTI-1066 at the starting dose.
Drug: HTI-1066 dose level 1
Starting dose level

Experimental: Cohort 2
Participants will receive HTI-1066 at dose level 2.
Drug: HTI-1066 dose level 2
2nd dose level

Experimental: Cohort 3
Participants will receive HTI-1066 at dose level 3.
Drug: HTI-1066 dose level 3
3rd dose level

Experimental: Cohort 4
Participants will receive HTI-1066 at dose level 4.
Drug: HTI-1066 dose level 4
4th dose level




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 2 year ]
    Number of participants with AEs and SAEs

  2. Dose-limiting toxicity (DLT) [ Time Frame: Up to 2 years ]
    Number of participants with DLTs


Secondary Outcome Measures :
  1. AUC [ Time Frame: Up to 1 year ]
    Area under the curve

  2. Cmax [ Time Frame: Up to 1 year ]
    Peak concentration at Tmax

  3. Anti-drug antibodies [ Time Frame: Up to 2 year ]
  4. Objective response rate [ Time Frame: Up to 2 years ]
  5. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥18 years of age
  2. Subject must have an advanced solid tumor
  3. ECOG Performance Status of 0 or 1
  4. Life expectancy ≥12 weeks
  5. Adequate laboratory parameters
  6. 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.
  7. Willing and able to comply with clinic visits and study-related procedures
  8. Provide signed informed consent

Exclusion Criteria:

  1. Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
  2. Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
  3. Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
  4. Any other prohibited or restricted medication as described in the study protocol.
  5. Investigational therapy administered <5 half-lives before the first dose of HTI-1066
  6. 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.
  7. Active CNS metastases.
  8. 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.
  9. History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
  10. 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)
  11. 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
  12. Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.
  13. Unresolved toxicities from previous anticancer therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398720


Contacts
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Contact: Junsheng Wang, MD, PhD +609 423 2155 ext 205 junsheng.wang@hengruitherapeutics.com
Contact: Matt Cromie, MSc +609 423 2155 ext 219 matt.cromie@hengruitherapeutics.com

Locations
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United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Vivek Khemka, MD, MBA, FACP       vivek.khemka@honorhealth.com   
United States, Tennessee
Sarah Cannon - Tennessee Oncology Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard A Burris, MD       howard.burris@sarahcannon.com   
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77230
Contact: Siqing Fu, MD    713-792-4318    siqingfu@mdanderson.org   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03398720    
Other Study ID Numbers: HTI-1066-101
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms