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Recruiting
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors
- Advanced Solid Tumor
- XTX202
Phase 1/Phase 2
Interventional
Primary Outcome:
- Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A only)
- Incidence of treatment-emergent adverse events (Phase 1 only)
- Incidence of changes in clinical laboratory values (Phase 1 only)
- Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only)
Secondary Outcome:
- Plasma concentrations of XTX202 (total and intact)
- Maximum observed plasma concentration (Cmax)
- Time of maximum observed concentration (Tmax)
- Trough concentrations (Ctrough)
- Area under the curve (AUC)
- Half-life (T1/2)
- Systemic clearance (CL)
- Volume of distribution (Vd)
- Antidrug antibody (ADA) occurrence and titer in serum (Phase 1 only)
- Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 1 only)
- Duration of response (DOR) (Phase 2 only)
- Disease control rate (Phase 2 only)
- Progression-free survival (PFS) (Phase 2 only)
- Overall survival (OS) (Phase 2 only)
- Incidence of treatment-emergent adverse events (Phase 2 only)
- Incidence of changes in clinical laboratory values (Phase 2 only)
189
January 18, 2022
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Xilio Development, Inc.
Xilio Development, Inc.
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors
NCT05052268
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.