NCT05970016 A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.
| NCT ID | NCT05970016 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Tide Pharmaceutical Co., Ltd |
| Condition | Patients with Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-08-07 |
| Primary Completion | 2025-07-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects who have provided voluntary informed consent for participation in the study and to follow the protocol requirements 2. Male or female subjects 18-70 years of age 3. Subjects with histologically or cytologically confirmed malignant advanced solid tumors who have progressed on (or have not been able to tolerate) standard therapy or for whom no suitable effective standard therapy exists 1. For Phase I, all tumor types will be enrolled 2. For Phase II, Patients with DDR defects detection at central laboratory will be enrolled 4. Subject with at least one measurable lesion according to RECIST criteria (version 1.1) for solid tumors will be allowed to include in phase II (if there is no measurable lesion but there are assessable lesions then the subject will be allowed to be included after the judgment of the investigator in phase I only) 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Subjects with life expectancy o