Clinical trial · Interventional
A Study of ZG2001 in Participants With KRAS Mutated Advanced Solid Tumours
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
NCT06237413CI-TRIAL-00074721unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS Mutation-Related Tumors | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZG2001 Tosilate Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Escalation
- description
- This Phase adopts an open-label design, with an Accelerated Titration(AT) design for the low-dose group (50 mg Bid) and the standard "3+3" design for the high-dose groups（100 mg Bid、50 mg Qd、100 mg Qd、200 mg Qd）.
- interventionNames
- Drug: ZG2001 Tosilate Tablets
- type
- EXPERIMENTAL
- label
- Phase 2 Dose Expansion
- description
- After the completion of the dose escalation study, RP2D will be selected for dose expansion in advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) with KRAS mutations that have failed at least the first-line standard treatment
- interventionNames
- Drug: ZG2001 Tosilate Tablets
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.