HRS-7058 for adults with advanced malignant tumors

An Open, Multicenter Phase I Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-7058 Monotherapy in Patients With Advanced Solid Tumour With KRAS G12C Mutation

This phase I effort will try different doses of the oral drug HRS-7058 in adults with advanced solid tumors to see if it is safe, how the body processes it, and whether it shows any anti-tumor effect.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 233 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06383871 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label Phase I dose-escalation, dose-extension, and efficacy-extension study of oral HRS-7058 in adults (18–75) with locally advanced or metastatic solid tumors and measurable disease. The study starts with dose-escalation cohorts to determine safety, tolerability, and pharmacokinetics, then moves to extension cohorts at selected doses to gather preliminary efficacy data. Key eligibility includes ECOG 0–1, adequate bone marrow and organ function, expected survival greater than three months, and ability to take oral medication. Primary endpoints focus on safety and tolerability, with secondary endpoints including pharmacokinetics and tumor response by RECIST 1.1.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced or metastatic solid tumors, at least one measurable lesion, ECOG performance status 0–1, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with poor performance status (ECOG ≥2), expected survival under three months, significant organ or marrow dysfunction, inability to take oral medication, or who are pregnant are unlikely to benefit from this early-phase trial.

Why it matters

Potential benefit: If successful, HRS-7058 could provide a new treatment option that slows tumor growth or extends survival for some patients with advanced solid tumors.

How similar studies have performed: Dose-escalation and expansion designs like this are standard in early oncology development and have produced effective drugs in other programs, but HRS-7058 itself appears to have limited or no published clinical data to date.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yifan Zhang

Conditions Advanced Malignant Tumour