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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03398720

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

33.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 31, 2017

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adverse events [Up to 2 year]
Number of participants with AEs and SAEs
Dose-limiting toxicity (DLT) [Up to 2 years]
Number of participants with DLTs

Secondary Outcome Measures

AUC [Up to 1 year]
Area under the curve
Cmax [Up to 1 year]
Peak concentration at Tmax
Anti-drug antibodies [Up to 2 year]
Objective response rate [Up to 2 years]
Progression-free survival (PFS) [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03398720

Other Study ID Numbers:

HTI-1066-101

First Posted:

Jan 12, 2018

Last Update Posted:

Jan 12, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jan 12, 2018