Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
CLDN18.2, gastric or gastroesophageal junction (GEJ) adenocarcinoma
Brief summary
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.
Detailed description
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.
Interventions
QLS31905 for Injection
DRUGQL2107 Injection
QL2107 Injection
Oxaliplatin Injection
DRUGCapecitabine Tablets
Capecitabine Tablets
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination; * Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD; * No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Exclusion criteria
* Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations; * Subjects had other second primary malignancies within 5 years prior to the first dose; * Subjects with clinically significant hemorrhage within 3 months before the first dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | up to 42 days following first dose | Dose Limiting Toxicity，for Dose Escalation Stage |
| MTD | up to 42 days following first dose | Maximum Tolerated Dose，for Dose Escalation Stage. |
| ORR (Objective Response Rate) | Approximately 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS (Progression Free Survival) | Approximately 24 months | 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). |
| OS (Overall Survival) | Approximately 24 months | 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. |
| AE (adverse events) | Approximately 24 months | 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. |
| Terminal elimination half-life (T1/2) | Approximately 24 months | T1/2 will be derived from the PK serum samples collected. |
| Maximum concentration (Cmax) | Approximately 24 months | Cmax will be derived from the PK serum samples collected. |
| Number of anti-drug antibody (ADA) Positive Participants | Approximately 24 months | Immunogenicity will be measured by the number of participants that are ADA positive. |
| DOR (Duration of Response) | Approximately 24 months | 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) |
Contacts
Primary ContactLin Shen, PHD
Outcome results
None listed