A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are capable of giving informed consent, have signed the informed consent form approved by the IRB/EC and noted the date, and are willing and able to comply with the treatment plan, visits, various examinations, and other procedural requirements.
Age must be between 18 and 75 years old (inclusive) when signing the informed consent form, gender is unrestricted.
ECOG score of 0 or 1.
Expected survival period ≥ 12 weeks.
Disqualifiers
Subjects with untreated or active CNS metastases, a history of meningeal metastasis, or current meningeal metastasis are not eligible for enrollment.
Start the study if the patient has received systemic anti-tumor treatment within 28 days prior to enrollment. If the patient has previously received small molecule targeted therapy, there must be an interval of at least 5 half-lives of that drug or 14 days, whichever is shorter, between the end of treatment and the first study treatment. If the patient has previously received traditional Chinese medicine or Chinese patent medicine for anti-tumor treatment, they may be enrolled if there is an interval of at least 14 days between the end of treatment and the first study treatment.
Palliative radiotherapy completed within 14 days before the first administration.
Unable to recover from the toxicity and/or complications of prior interventions to CTCAE ≤ Grade 1 (excluding conditions such as alopecia, Grade 2 peripheral neuropathy, and other situations deemed by the investigator not to affect the treatment with the investigational drug that meet the numerical requirements in the enrollment criteria).
Trial design
Design model
Single group
Treatments tested in this trial
HRS-7058
DrugHRS-7058 combined with antitumor drugs.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: HRS-7058Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of dose-limiting toxicities (DLT).
Time frame
About 28 days.2
The incidence and severity of adverse events (AEs).
According to NCI-CTCAE v5.0 standards.
Time frame
About 28 days.3
Recommended Phase 2 Dose (RP2D) of HRS-7058 in combination with antitumor drugs in subjects with solid tumors.
Time frame
From the first dose to the last visit, about 12 months.Secondary outcomes
1
The duration of response (DoR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame
From the first dose to the last visit, about 12 months.2
The objective response rate (ORR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame
From the first dose to the last visit, about 12 months.3
The disease control rate (DCR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame
From the first dose to the last visit, about 12 months.4
The progression-free survival (PFS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs.
Time frame
From the first dose to the last visit, about 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov