A Trial of HTI-1090 in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HTI-1090

• Registration Number: NCT03208959
• Lead Sponsor: Atridia Pty Ltd.

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.

Detailed Description

This is an open-label, dose escalation, phase I, study of HTI-1090 (also known as SHR9146), a small molecule that inhibits both indoleamine 2,3-dioxygenase 1 (IDO1) and tryptophan 2,3-dioxygenase (TDO) - two enzymes that catalyze the oxidation of L-tryptophan (Trp) into kynurenine (Kyn), thereby interrupting the immune escape and the attainment of immunologic tolerance. Dose escalation will use a modified "3+3" design and continue until a MTD or RP2D is identified. This study will also characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HTI-1090 in subjects with advanced solid tumors.

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2017-08-30
• Primary Completion: 2018-11-01
• Study Completion: 2019-01-23
• Status Verified: 2019-09
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 3	HTI-1090	100% Increment from dose level 2
Dose level 2	HTI-1090	100% Increment from dose level 1
Dose level 5	HTI-1090	50% Increment from dose level 4
Dose level 4	HTI-1090	100% Increment from dose level 3
Dose level 1	HTI-1090	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

Primary Outcome Measures

Name	Time	Method
Vital signs	Cycle 1 (each cycle is 21 days)	Incidence of vital sign abnormalities
Electrocardiogram	Cycle 1 (each cycle is 21 days)	Incidence of ECG abnormalities
Adverse events	Cycle 1 (each cycle is 21 days)	Incidence of AEs
Laboratory results	Cycle 1 (each cycle is 21 days)	Incidence of laboratory abnormalities

Trial Locations

Locations (1)

Icon Cancer Care Centre; 🇦🇺 South Brisbane, New South Wales, Australia