Clinical Trials /

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

NCT03398720

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: HTI-1066-101
  • NCT ID: NCT03398720

Conditions

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
HTI-1066 dose level 1Cohort 1
HTI-1066 dose level 2Cohort 2
HTI-1066 dose level 3Cohort 3
HTI-1066 dose level 4Cohort 4

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalOne participant will receive HTI-1066 at the starting dose.
  • HTI-1066 dose level 1
Cohort 2ExperimentalParticipants will receive HTI-1066 at dose level 2.
  • HTI-1066 dose level 2
Cohort 3ExperimentalParticipants will receive HTI-1066 at dose level 3.
  • HTI-1066 dose level 3
Cohort 4ExperimentalParticipants will receive HTI-1066 at dose level 4.
  • HTI-1066 dose level 4

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events
Time Frame:Up to 2 year
Safety Issue:
Description:Number of participants with AEs and SAEs

Secondary Outcome Measures

Measure:AUC
Time Frame:Up to 1 year
Safety Issue:
Description:Area under the curve
Measure:Cmax
Time Frame:Up to 1 year
Safety Issue:
Description:Peak concentration at Tmax
Measure:Anti-drug antibodies
Time Frame:Up to 2 year
Safety Issue:
Description:
Measure:Objective response rate
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

Last Updated