A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour

Phase 1

Recruiting

• Conditions: Advanced Malignant Tumour
• Interventions: Drug: HRS-7058 capsule/ HRS-7058 tablet

• Registration Number: NCT06383871
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-25
• Study Start: 2024-06-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
2. 18 to 75 years old (including both ends), gender is not limited;
3. Subjects with locally advanced or metastatic solid tumour confirmed by histopathology;
4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
5. ECOG Performance Status of 0 or 1;
6. The expected survival time is more than 3 months;
7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
8. Adequate bone marrow and organ function;
9. Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;
10. For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.

Exclusion Criteria

1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
2. Had other malignancies within five years prior to first use of the investigational drug;
3. With severe cardiovascular and cerebrovascular disease；
4. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
5. The presence of uncontrolled pleural, abdominal or pericardial effusion;
6. Severe infection within 4 weeks prior to initiation of study treatment;
7. History of immune deficiency;
8. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
9. Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug;
10. Had undergone major organ surgery within 4 weeks prior to the first use of the study drug;
11. Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period;
12. Known allergies and contraindications to the investigational drug or any of its components;
13. In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-7058	HRS-7058 capsule/ HRS-7058 tablet	-

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose (MTD)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Phase II recommended dose (RP2D)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Dose-limiting toxicity (DLT)	From the beginning of first patient in (FPI) to the end of dose escalation phase up to approximately 10 months
Safety endpoints: adverse events (AE)	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months]

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion	From the beginning of first patient in (FPI) to the end of study up to approximately 21 months
Efficacy endpoints: overall survival (OS)	From the beginn ing of first patient in (FPI) to the end of study up to approximately 21 months

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China