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

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



Sponsors


Source

Jiangsu HengRui Medicine Co., Ltd.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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.

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.

Overall Status

Recruiting

Start Date

2017-12-31

Completion Date

2019-12-31

Primary Completion Date

2018-12-31

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Adverse events
Up to 2 year
Dose-limiting toxicity (DLT)
Up to 2 years

Secondary Outcome

Measure

Time Frame

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

Enrollment

100

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Starting dose level

Arm Group Label

Cohort 1


Intervention Type

Drug

Intervention Name


Description

2nd dose level

Arm Group Label

Cohort 2


Intervention Type

Drug

Intervention Name


Description

3rd dose level

Arm Group Label

Cohort 3


Intervention Type

Drug

Intervention Name


Description

4th dose level

Arm Group Label

Cohort 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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Junsheng Wang, MD, PhD

Phone

+609 423 2155

Phone Ext

205

Email



Location

Facility

Status

Contact

Honor Health Research Institute
Scottsdale Arizona 85258 United States
Recruiting
Last Name: Vivek Khemka, MD, MBA, FACP
Email: [email protected]
Sarah Cannon - Tennessee Oncology
Nashville Tennessee 37203 United States
Not yet recruiting
Last Name: Howard A Burris, MD
Email: [email protected]
MD Anderson Cancer Center
Houston Texas 77230 United States
Not yet recruiting
Last Name: Siqing Fu, MD
Phone: 713-792-4318
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-01-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Number Of Arms

4

Arm Group

Arm Group Label

Cohort 1

Arm Group Type

Experimental

Description

One participant will receive HTI-1066 at the starting dose.


Arm Group Label

Cohort 2

Arm Group Type

Experimental

Description

Participants will receive HTI-1066 at dose level 2.


Arm Group Label

Cohort 3

Arm Group Type

Experimental

Description

Participants will receive HTI-1066 at dose level 3.


Arm Group Label

Cohort 4

Arm Group Type

Experimental

Description

Participants will receive HTI-1066 at dose level 4.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Matt Cromie, MSc

Phone

+609 423 2155

Phone Ext

219

Email



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

December 26, 2017

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 6, 2018

Last Update Submitted Qc

January 6, 2018

Last Update Posted

January 12, 2018


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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