Vactosertib in Combination With Pembrolizumab in Metastatic Colorectal or Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedPacto, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

1. WHO / ECOG /PS of 0 or 1 at enrollment

2. Must have a life expectancy of at least 12 weeks

3. Patients with histologically or cytologically confirmed advanced or metastatic colorectal cancer who have disease progression after treatment with all available therapies including fluoropyrimidine and oxaliplatin or irinotecan for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.

4. Histologically- or cytologically- confirmed, advanced or metastatic diffuse-type adenocarcinoma of the stomach or gastroesophageal (GE) junction who have had disease progression after at least two previous courses of chemotherapy for metastatic disease, which should include fluoropyrimidine and platinum.

5. Confirmation of measurable disease based on RECIST 1.1

6. ICI-naïve patients

7. Adequate organ and marrow function as defined below: Bilirubin≤1.5 ×ULN ,AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases) ,INR OR PT ≤1.5 × ULN , ANC ≥1500/µL , Platelets ≥100 000/µL, Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L1, Creatinine ≤1.5 × ULN

Exclusion Criteria:

1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

2. Has received prior radiotherapy within 2 weeks of start of study treatment.

3. Has received a live vaccine within 30 days prior to the first dose of study drug

4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

5. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

6. Has known CNS metastases and/or leptomeningeal involvement

7. Judgement by the investigator that the patient should not participate in the study .