A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors

An Open-label, Multi-center Phase I Study of Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors

The study is being conducted to evaluate the efficacy, andsafety of HRS-6209in subjects with advanced solid tumors.To explore the reasonable dosage of HRS-6209.This study also preliminarily evaluated the efficacy of HRS-6209 in patients with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HRS-6209

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu; Phone Number: 0518-82342973; Email: xiaoyu.zhu@hengrui.com
• Study Contact Backup: Name: Yueling Wang; Phone Number: 021-60453139; Email: yueling.wang@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
2. Aged 18-80 years, male or female
3. Patients with advanced malignant tumors confirmed pathologically;
4. Failure of adequate standard treatment, or no effective standard treatment;
5. Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1 ;
6. The expected survival period is more than 12 weeks;
7. The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
8. Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days)；
9. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 6 months after the last administration of the study drug Measures: For male subjects whose partners are females of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study administration;

Exclusion Criteria:

1. Subjects with a history of malignant tumors, except patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical carcinoma in situ who have undergone possible curative treatment and did not have disease recurrence within 3 years since starting the treatment；
2. Subjects had cancerous meningitis or untreated central nervous system metastases
3. Subjects experienced intestinal obstruction and gastrointestinal perforation within 3 months prior to initial medication
4. There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion)；
5. Subjects had clinical cardiac symptoms or disease that was not well controlled within 6 months prior to initial medication
6. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia；
7. Arteriovenous thrombosis occurred within 6 months prior to the first dose
8. Severe infection occurred within 4 weeks prior to initial administration
9. During the screening period/before the first administration, fever of unknown origin> 38.5°C
10. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS)
11. Subjects had active hepatitis；
12. Subjects received live attenuated vaccine within 4 weeks or planned for the study period prior to initial administration；
13. Subjects were scheduled to receive other systemic antitumor therapies during the study period；
14. Participated in other clinical studies within 4 weeks before starting the study drug treatment；
15. Subjects were unable to swallow pills or capsules normally, or had gastrointestinal abnormalities that the researchers determined might affect drug absorption；
16. Other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-6209	Drug: HRS-6209; HRS-6209

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety endpoints: Number of subjects with adverse events and the severity of adverse events	every 4 weeks after treatment initiation，up to approximately 2 years.
DLT(Dose-limiting toxicity）	during the first 30-day cycle of SHR-6209 treatment
MTD（Maximum tolerated dose）	4 weeks after treatment initiation
RP2D（Recommended Phase II Dose）	4 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR（Objective response rate (ORR) - RECIST 1.1	ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1）	Up to approximately 6 months
DoR（Duration of Response (DoR)Duration of Response (DoR) per RECIST 1.1）		Up to approximately 2 years
DCR（Disease control rate（DCR）-RECIST 1.1	DCR is defined as the proportion of subjects who have achieved Stable disease(SD)、complete response (CR) or partial response (PR) according to RECIST 1.1）	Up to approximately 2 years
PFS-Progression-free survival(PFS) PFS per RECIST 1.1		Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 30, 2026
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HRS-6209-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No