NCT06632262 A Phase 2 Clinical Study of ABSK061 and ABSK043
| NCT ID | NCT06632262 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Abbisko Therapeutics Co, Ltd |
| Condition | HER2-Gastric/Gastroesophageal Junction Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2029-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations
Eligibility Criteria
Inclusion Criteria: * Patients must have a measurable target lesion (per RECIST v1.1) (not applicable to expansion cohort 1) where: * Dose Escalation: patients with histologically confirmed solid tumors who have progressed after standard of care, are unable to tolerate standard therapy, or have no standard of care currently available: * Patients must have the a central laboratory or previous test report confirming FGFR2/3 gene activatingon alterations (including FGFR2/3 activating mutations, fusions/rearrangements, or FGFR2 amplifications) or overexpression in tumor tissue or blood based on central laboratory test or previous test reports. * Expansion Phase: * Cohort 1 (HER2-gastric/gastroesophageal junction cancer) * Histologically or cytologically confirmed metastatic/unresectable gastric/gastroesophageal junction cancer, HER2 test negative * The patient had FGFR2 amplification or overexpression in tumor tissue confirmed by a central laboratory test or a previous test report (previou
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