A Phase 2 interventional study of QLS31905 for Injection and QL2107 Injection in Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.
QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.
This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
QLS31905+QL2107+ oxaliplatin + capecitabine
Drug: QLS31905 for Injection · Drug: QL2107 Injection · Drug: Oxaliplatin Injection · Drug: Capecitabine Tablets
QLS31905 for Injection
QL2107 Injection
Oxaliplatin Injection
Capecitabine Tablets
DLT
Dose Limiting Toxicity，for Dose Escalation Stage
Time frame: up to 42 days following first dose
MTD
Maximum Tolerated Dose，for Dose Escalation Stage.
Time frame: up to 42 days following first dose
ORR (Objective Response Rate)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1
Time frame: Approximately 24 months
AE (adverse events)
AEs are any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Approximately 24 months
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Time frame: Approximately 24 months
DOR (Duration of Response)
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first)
Time frame: Approximately 24 months
PFS (Progression Free Survival)
PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).
Time frame: Approximately 24 months
OS (Overall Survival)
OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
Time frame: Approximately 24 months
Maximum concentration (Cmax)
Cmax will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
Terminal elimination half-life (T1/2)
T1/2 will be derived from the PK serum samples collected.
Time frame: Approximately 24 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd.