Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study.
Eligibility criteria
Qualifiers
Able and willing to provide a written informed consent;
Age ≥18 years old, gender unlimited;
The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1;
Life expectancy Predicted survival ≥3 months;
Disqualifiers
Plan to receive any other antitumor therapy during this trial;
Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;
Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;
Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;
Trial design
Treatments tested in this trial
- SHR-A2102
Treatment groups
395 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov