A Phase 1b/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination with Pembrolizumab in Patients with Metastatic or Locally Advanced Colorectal or Gastric Cancer/ Gastroesophageal Junction Adenocarcinoma
Overview
- Phase
- Phase 1
- Intervention
- TEW-7197
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- MedPacto, Inc.
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- Safety and Tolerability
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is an open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, and antitumor activity of vactosertib in combination with pembrolizumab in patients with metastatic or locally advanced colorectal or gastric/gastroesophageal junction adenocarcinoma
Detailed Description
This is phase 1b/2a, open label, multi-center study to assess safety, tolerability, pharmacokinetics and anti-tumor activity of vactosertib in combination with pembrolizumab in patients with mCRC including CMS4 or diffuse GC/GEJC with two phases (Dose Finding Phase and Dose Expansion Phase). At screening, CMS4 will be classified by an experienced pathologist in the central lab that will examine the histology of primary surgical tissues. Approximately, 67 total patients are expected to be enrolled in this study. The first phase of the study, the Dose Finding Phase, will determine the MTD of the combination regimen. The second phase, the Dose Expansion Phase, will further evaluate the combination regimen to confirm RP2D.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose Expansion (300mg BID)
TEW-7197 300mg BID, 5D/W + Pembrolizumab 200mg Q3W (n= 30)
Intervention: TEW-7197
Dose Expansion (200mg BID)
TEW-7197 200mg BID, 5D/W + Pembrolizumab 200mg Q3W (n= 30)
Intervention: TEW-7197
Dose Expansion (200mg QD)
TEW-7197 200mg QD, 5D/W + Pembrolizumab 200mg Q3W (n= 30)
Intervention: TEW-7197
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: approximately 2 years
Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE v5.0
Maximum Tolerated Dose
Time Frame: approximately 2 years
Incidence of nature of DLTs
Secondary Outcomes
- Efficacy 3(up to 3 years)
- Efficacy 1(approximately 2 years)
- Efficacy 2(approximately 2 years)