A Phase 1/2 interventional study of SHR-A2102+HRS-4642 in Solid Tumors, sponsored by Henan Cancer Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Henan Cancer Hospital · Phase 1/2, Interventional, and Treatment
The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors
This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 32 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SHR-A2102+HRS-4642
Drug: SHR-A2102+HRS-4642
A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.
Dose Limited Toxicity(DLT)
one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
Time frame: At the end of Cycle 1 (each cycle is 14 days)
Objective Response Rate (ORR)
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: up to 1 year
Progression-free Survival (PFS)
the time from treatment initiation to the first disease progression or death from any cause
Time frame: up to 2 year
Overall survival(OS)
the time from treatment initiation until death from any reason
Time frame: up to 2 year
Disease Control Rate (DCR)
the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Time frame: up to 1 year
Duration of response (DoR)
Assessed by Investigator According to RECIST v1.1
Time frame: up to 1 year
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory
Assess safety and tolerability by way of adverse events (CTCAE v5.0)
Time frame: Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years.
Plan to share: No
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital