Solid Tumor Clinical Trial
Official title:
A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | February 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose Limiting Toxicity (DLT) | 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. | Up to 21 Days | |
Primary | Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 | Up to 24 Months |
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