KRAS Mutation-Related Tumors, Solid Tumor
Conditions
Brief summary
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
Interventions
DRUGZG2001 Tosilate Tablets
ZG2001 will be administered orally once or twice daily in a continuous regimen
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
* Participants who fully understood this study and voluntarily signed the informed consent form; * Men or women ≥ 18 years old; * Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit. * ECOG Performance Status (PS) 0 or 1; * Life expectancy \> 3 months.
Exclusion criteria
* Received any SOS1 inhibitors; * Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study; * Other conditions that the investigator considers to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to 24 Months | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 |
| Dose Limiting Toxicity (DLT) | Up to 21 Days | A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out. |
Countries
China
Contacts
Primary ContactCheng Wei
Outcome results
None listed