A Study of HS248 in Patients With Advanced Solid Tumors

NCT05759234 | Unknown Phase 1

• 1 other identifier: HS248-I-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Peak Plasma Concentration (Cmax)

  From date of initial dose until up to 33 days for treatment

• Area Under the Plasma Concentration versus Time Curve (AUC)

  From date of initial dose until up to 33 days for treatment

• ORR

  Up to 2 years

• DOR

  Up to 2 years

• PFS

  Up to 2 years

Study Arms (1)

HS248 pieces

EXPERIMENTAL

dose escalation period： At this stage, it is planned that HS248 will adopt the traditional "3+3" method of increasing doses at four dose levels of 20 mg, 40 mg, 60 mg and 80 mg. All dosage components are divided into single administration stage and multiple administration stage. After 5 days of observation after single administration, it enters the stage of multiple administration. In the stage of multiple administration, HS248 is administered once a day (qd) for 28 days. a treatment cycle. 33 days after the first administration (the 5-day observation period in the single-administration phase and the first cycle in the multiple-administration phase) is the dose-limiting toxicity (DLT) observation period of this study

Drug: HS248 pieces

Interventions

HS248 pieces DRUG

The overall safety and tolerability of PI3Kγ inhibitor monotherapy for solid tumors is good, and it has shown preliminary clinical benefits. The safety of PI3Kγ 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 PI3Kγ 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.

HS248 pieces

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical trial, understand and follow the research procedures and voluntarily sign the ICF;
• Male or female, age ≥18 when signing the ICF;
• Expected survival period ≥ 12 weeks;
• 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);
• Eastern Cooperative Oncology Group (ECOG) physical status score 0-1

You may not qualify if:

• Symptomatic or untreated central nervous system metastasis or primary central nervous system malignancy;
• 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;
• Previous history of autoimmune diseases, stem cell transplantation or organ transplantation;
• 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;
• Peptic ulcer and/or gastrointestinal bleeding at present or in the past;
• Gastrointestinal dysfunction that may limit the absorption of the test drug, including motility disorders, malabsorption syndrome or inflammatory bowel disease;

Sponsors & Collaborators

• Hanhui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Guo, professor

CONTACT

0571-8168910X; Wei.Qu@hanhui-pharma.com

Tang, MD&PhD

CONTACT

0571-8168910X; Wenping.Wang@hanhui-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At this stage, it is planned that HS248 will adopt the traditional "3+3" method of increasing doses at four dose levels of 20 mg, 40 mg, 60 mg and 80 mg. All dosage components are divided into single administration stage and multiple administration stage. After 5 days of observation after single administration, it enters the stage of multiple administration. In the stage of multiple administration, HS248 is administered once a day (qd) for 28 days. a treatment cycle. 33 days after the first administration (the 5-day observation period in the single-administration phase and the first cycle in the multiple-administration phase) is the dose-limiting toxicity (DLT) observation period of this study

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 8, 2023
• Study Start: November 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)