Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06243354
PHASE1/PHASE2

Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation

Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Official title: An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

257

Start Date

2024-02-04

Completion Date

2026-12

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

Test product: HYP-2090PTSA

Dosage form: Capsule. Strength: 2.5 mg, 5 mg and 10mg. Method of administration: Take orally on an empty stomach. Do not chew. Swallow the product with warm water. Dose Escalation Phase PK Lead-in Period (C0D1 only): Take once (QD dosing regimen only). Starting from C1D1, and in the Dose Expansion part, subjects will take the protocol-specified dose of HYP-2090PTSA orally in the morning on an empty stomach and one hour before the evening meal (evening dosing applies to BID regimen only), administered once to twice daily or two to three times per week. The administration dosages are: QD (once daily); BID (twice daily); TIW (on Days 1, 3, and 5 of each week); BIW (on Days 1 and 4 of each week). Avoid drinking water as much as possible within 1 hour before and after dosing (except for the water taken with the medication). Do not re-administer the dose if vomiting occurs after drug intake.

Locations (6)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Hunan Provincial Cancer Hospital

Changsha, Hunan, China

The first Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Provincial Cancer Hospital

Jinan, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China