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Protocol # 21-441

Status

Recruiting

Description

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.

Condition

  • Advanced Solid Tumor

Interventions

  • XTX101
  • Pembrolizumab
  • XTX101

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of Dose Limiting Toxicities (DLTs) (Part 1A and Part 1C only)
  • Incidence of treatment-emergent adverse events and changes in clinical laboratory abnormalities (Part 1A, 1B & 1C only)
  • Incidence changes in clinical laboratory (Part 1A, 1B & 1C only)
  • Investigator-assessed objective response rate (ORR) per iRECIST (Part 2 only)

Secondary Outcome:

  • Investigator-assessed objective response rate (ORR) per iRECIST (Part 1A, 1B & 1C only)
  • Antidrug antibody (ADA) occurrence and titer in serum (Part 1A, 1B & 1C only)
  • Plasma concentrations of XTX101 (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)
  • Duration of response (Part 2 only)
  • Disease control rate (Part 2 only)
  • Progression-free survival (Part 2 only)
  • Overall survival (Part 2 only)
  • Incidence of treatment-emergent adverse events and changes in clinical laboratory abnormalities (Part 2 only)
  • Incidence changes in clinical laboratory (Part 2 only)

Enrollment

144

Study Start Date

September 13, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Xilio Development, Inc.

Source

Xilio Development, Inc.

Official title

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX101 Monotherapy and XTX101 and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT04896697

     

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.