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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03208959




Registration number
NCT03208959
Ethics application status
Date submitted
26/04/2017
Date registered
6/07/2017
Date last updated
30/09/2019

Titles & IDs
Public title
A Trial of HTI-1090 in Subjects With Advanced Solid Tumors
Scientific title
A Phase I, Open-Label, Multicenter, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of HTI-1090 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
HTI-1090-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HTI-1090

Experimental: Dose level 1 - HTI-1090 tablets will be orally administered on an empty stomach,twice daily, BID i.e., dosing will be 12 hours apart and at approximately the same times each day

Experimental: Dose level 2 - 100% Increment from dose level 1

Experimental: Dose level 3 - 100% Increment from dose level 2

Experimental: Dose level 4 - 100% Increment from dose level 3

Experimental: Dose level 5 - 50% Increment from dose level 4


Treatment: Drugs: HTI-1090
IDO/TDO inhibitor

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events - Incidence of AEs
Timepoint [1] 0 0
Cycle 1 (each cycle is 21 days)
Primary outcome [2] 0 0
Laboratory results - Incidence of laboratory abnormalities
Timepoint [2] 0 0
Cycle 1 (each cycle is 21 days)
Primary outcome [3] 0 0
Vital signs - Incidence of vital sign abnormalities
Timepoint [3] 0 0
Cycle 1 (each cycle is 21 days)
Primary outcome [4] 0 0
Electrocardiogram - Incidence of ECG abnormalities
Timepoint [4] 0 0
Cycle 1 (each cycle is 21 days)

Eligibility
Key inclusion criteria
To be eligible to participate in this study, each subject must meet all of the following
criteria:

1. Provision of signed fully informed consent prior to any study specific procedures

2. Male or female aged 18 years or older

3. Diagnosed (histologically or cytologically) with solid tumors and documented as
advanced or metastatic disease for which there is no known effective anti-tumor
treatment (refractory to or relapsed from standard therapies)

4. Subjects may have received one prior IDO, or TDO, or IDO/TDO dual inhibitor therapy;
PD-1 or PD-L1 inhibitor; or other therapy that targets T cell co-stimulation or
co-inhibition more than 4 weeks prior to the first dose of HTI-1090 (Cycle 1, Day 1)

5. An ECOG Performance Status (PS) of 0 or 1

6. Have a life expectancy = 12 weeks from proposed first dose date

7. Patients must have had no recent major surgery, radiotherapy or chemotherapy over the
past 28 days and be fully recover from toxicity before dosing

8. Adequate laboratory parameters during the Screening Period as evidenced by:

- Absolute neutrophil count = 1.5×109/L (1,500/mm3)

- Platelets = 100×109/L (100,000/mm3)

- Hemoglobin (Hgb) = 9.0 g/dL (90 g/L)

- Subjects may be transfused with red blood cells to improve Hgb levels.

- Total bilirubin = 1.5×ULN (= 2×ULN for subjects with liver metastases)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5×ULN;
for subjects with liver metastases, ALT and AST = 5×ULN

- Serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min (measured or
calculated by Cockcroft-Gault method)

- Clinically relevant and treatment resistant abnormalities in potassium, sodium,
calcium (corrected for plasma albumin) or magnesium

9. Evidence of post-menopausal status, permanent or surgically sterile, or negative serum
pregnancy test for female patients of child-bearing potential. Women will be
considered post-menopausal if they are over 50 years old and have been amenorrhoeic
for 12 months or more following cessation of all exogenous hormonal treatments.
Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or
bilateral salpingectomy but excludes bilateral tubal occlusion. Tubal occlusion is
considered a highly effective method of birth control but does not absolutely exclude
the possibility of pregnancy. (The term occlusion refers to both occluding and
ligating techniques that do not physically remove the oviducts). Women who have
undergone tubal occlusion should be managed as if they are of child-bearing potential
(e.g., undergo pregnancy testing as required by the study). Females of reproductive
potential are required to use reliable contraception

10. Patients must have ability to take and retain oral medication and have no
malabsorption problems

11. Willing and able to return to treatment center for follow up, as outlined as protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Icon Cancer Care Centre - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
IDO1 is expressed in a wide variety of human tumors (eg. bladder, breast, colon, DLBCL,
HNSCC, lung, ovarian, uterine, renal…), and contributes to tumoral resistance. HTI-1090 (also
referred as SHR9146 in nonclinical study reports) is an orally bioavailable, highly potent,
novel small-molecule IDO1/TDO dual inhibitor, with favorable preclinical oral bioavailability
and safety profiles.
Trial website
https://clinicaltrials.gov/show/NCT03208959
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications