A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237413
• Other study ID #: ZG2001-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 10, 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Cheng Wei
• Phone: +86-0512-57309965
• Email: weic[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• KRAS Mutation-Related Tumors
• Neoplasms
• Solid Tumor

Intervention

Drug:
• ZG2001 Tosilate Tablets
ZG2001 will be administered orally once or twice daily in a continuous regimen

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

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