A Study of HS248 in Patients With Advanced Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759234
• Other study ID #: HS248-I-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Hanhui Pharmaceutical Co., Ltd
• Contact: Guo, professor
• Phone: 0571-8168910X
• Email: Wei.Qu[@]hanhui-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。

Description:

Main purpose: Assess the safety and tolerability of HS248 in patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of HS248. Secondary purpose: Secondary purpose: Assess the pharmacokinetic (PK) profile of HS248 in patients with advanced solid tumors; To evaluate the preliminary antitumor activity of HS248 in patients with advanced solid tumors. Preliminary antitumor activity in patients with advanced solid tumors. Other purposes: Population-based PK (PopPK) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description of HS248 in patients with advanced solid tumors PK features in; Evaluate the relationship between exposure and efficacy and adverse events (AEs) of HS248 in patients with advanced solid tumors, as data permit; To explore the changes of HS248 in myeloid-derived suppressor cells (MDSC) and CD8+ T cells in patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntarily participate in this clinical trial, understand and follow the research procedures and voluntarily sign the ICF;

2. Male or female, age =18 when signing the ICF;

3. Expected survival period = 12 weeks;

4. Patients with advanced solid tumors confirmed by histology/cytology, who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment plan (patients with multiple solid tumors are included in the dose-escalation phase, and the population included in the dose-expansion phase will be based on dose escalation phase study data and the potential advantageous population of similar drugs);

5. Eastern Cooperative Oncology Group (ECOG) physical status score 0-1

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis or primary central nervous system malignancy;

2. Other known malignant tumors in the past 5 years, except cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate;

3. Previous history of autoimmune diseases, stem cell transplantation or organ transplantation;

4. Known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic obstruction caused by gallstones, cirrhosis or portal hypertension;

5. Peptic ulcer and/or gastrointestinal bleeding at present or in the past;

6. Gastrointestinal dysfunction that may limit the absorption of the test drug, including motility disorders, malabsorption syndrome or inflammatory bowel disease;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• HS248 pieces
The overall safety and tolerability of PI3K? inhibitor monotherapy for solid tumors is good, and it has shown preliminary clinical benefits. The safety of PI3K? inhibitor combined with immune checkpoint inhibitor is good, and the efficacy of single drug is significantly improved. Based on the evaluation of the safety and efficacy results of HS248 preclinical and clinical studies of similar PI3K? inhibitors, the benefits of this product outweigh the risks for patients with advanced solid tumors who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment regimen. Sufficient to support planned clinical studies.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hanhui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	To examine the incidence of clinical and laboratory adverse events after multiple doses of HS-248 in the dose escalation and dose expansion phases	From first dose of HS248 through 28 days after the last HS248 treatment (up to 2 years); each cycle is 28 days
Primary	MTD and/or RP2DP2D	MTD and/or RP2DP2D	The end of the study is defined as the last subject completing the last visit, study treatment for 2 years, loss to follow-up, death or withdrawal of informed consent, whichever occurs first
Secondary	Peak Plasma Concentration (Cmax)	Cmax of HS248	From date of initial dose until up to 33 days for treatment
Secondary	Area Under the Plasma Concentration versus Time Curve (AUC)	AUC of HS248	From date of initial dose until up to 33 days for treatment
Secondary	ORR	Objective Response Rate	Up to 2 years
Secondary	DOR	Duration of Remission	Up to 2 years
Secondary	PFS	Progression-Free Survival	Up to 2 years
Secondary	DCR	Disease Control Rate	Up to 2 years
Secondary	OS	Overall Survival	Up to 2 years