KRAS G12C Mutant Advanced Solid Tumors
Conditions
Brief summary
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.
Interventions
DRUGZG19018
ZG19018 Given by PO (mouth)
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who fully understood this trial and voluntarily signed the informed consent form; * Men or women ≥ 18 years old; * ECOG Performance Status (PS) 0 or 1; * Life expectancy \> 3 months.
Exclusion criteria
* Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.; * Patients requiring medications that can potentially prolong QTc interval; * Other conditions that the investigator considers to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Up to 21Days | A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the first treatment cycle of ZG19018 (day 1 through day 21) where elationship to ZG19018 cannot be ruled out. |
| Objective Response Rate (ORR) | Up to 24 Months | The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria. |
Countries
China
Contacts
Primary ContactCheng Wei
Outcome results
None listed