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Association details:
| Biomarker: | CLDN18.2 positive |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | MIL93 (CLDN18.2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Clinical Study of MIL93 in Solid Tumors.
Excerpt:
...Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer....
Trial ID:
Source:
Title:
Safety, tolerability, pharmacokinetics and preliminary efficacy of MIL93, an anti-Claudin18.2 monoclonal antibody, in patients with advanced solid tumors: A phase 1 clinical study.
Published date:
05/26/2022
Excerpt:
In particular, Grade 3 nausea and vomiting occurred in 2 cases in the third dose group, so preventive antiemetic treatment was given from the fourth dose group. 9 pts (69.2%) experienced at least one treatment-emergent adverse event (TEAE) with no Grade 4 or Grade 5 AEs. The most common treatment-related adverse events (TRAEs) occurring in ≥10% of pts were nausea (46.2%), vomiting (46.2%), fatigue (15.4%), anemia (15.4%). Serious adverse events (SAEs) were observed in 3 (23.1%) pts, and MIL93-related SAEs occurred in 1 pt (7.7%, Grade 3 nausea). Among the 10 pts who had at least one post-treatment radiological evaluation, 1 pt with CLDN18.2-positive gastric cancer achieved PR and 3 pts had SD, including 1 case of gastric cancer, 1 case of gastroesophageal junction cancer and 1 case of gallbladder cancer.MIL93 had a favorable safety profile with no DLTs observed through 20mg/kg Q3W. Pts with CLDN18.2-positive gastric cancer responded to the treatment.
Trial ID:
