SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
This study consists of two research phases:
Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.
Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
Eligibility criteria
Qualifiers
Age 18 to 75 years old (including boundary values);
Volunteer to participate in this clinical study and sign informed consent;
ECOG score 0-1;
Expected survival ≥3 months;
Disqualifiers
Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
HER2 expression in tumor tissue is positive.
The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
Has ≥ grade 2 peripheral sensory neuropathy.
Trial design
Treatments tested in this trial
- SHR-A1904; Adebrelimab
- SHR-A1904; CAPOX; Adebrelimab
Treatment groups
924 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov