Status:
TERMINATED
Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis
Lead Sponsor:
Highlight Therapeutics
Conditions:
Colorectal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered intratumorally in combination with intravenous pembrolizumab in patients with liver metastasis from colorect...
Detailed Description
The purpose of this Phase II study is to evaluate the safety, tolerability, antitumoural activity and systemic exposure of repeated IT administrations of BO-112 percutaneously injected into a hepatic ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Nonresectable liver metastasis(es) of colorectal or gastric/gastro-oesophageal junction cancer (GC/GEJ). History of resection for liver metastasis is allowed.
- Histological or cytological proof of colorectal (Cohort A) or GC/GEJ cancer (Cohort B).
- Progression during or after, or have not tolerated therapy for advanced/metastatic disease as follows:
- Cohort A (CRC): at least 2 lines of fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy with or without bevacizumab; if epidermal growth factor receptor (EGFR) positive/RAS wild type, prior anti-EGFR treatment is required. Incase of prior resection of hepatic metastasis with hepatic recurrence, only 1 prior line of fluoropyrimidine, irinotecan and/or oxaliplatin containing therapy is required.
- Cohort B (GC/GEJ): fluoropyrimidine and platinum containing treatment; if Human epidermal growth factor receptor 2 (HER-2) positive, also prior anti-HER-2 treatment is required.
- At least 1 liver metastasis of minimum 20 mm in diameter that is suitable for percutaneous, IT injection .
- Presence of at least 1 measurable lesion according to RECIST v1.1. Note: this may be the liver metastasis selected for injection if it is the only measurable lesion present.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate haematologic and end-organ function
- EXCLUSION CRITERIA
- Prior treatment with an anti-PD1, anti-PDL1 or anti-PDL2 agent, an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) or any Toll-like receptor (TLR) agonist.
- Liver metastasis(es) with macroscopic tumour infiltration into the main portal vein, hepatic vein or vena cava.
- Contraindications to tumour biopsy and injections of the hepatic metastasis(es).
- Chemotherapy, definitive (curative) radiation, or biological cancer therapy within 4 weeks prior to the first dose of study treatment.
- Palliative radiotherapy (≤ 2 weeks of radiotherapy) within 1 week of start of study treatment.
- Clinically active central nervous system (CNS) metastases and/or carcinomatosis meningitis.
Exclusion
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04508140
Start Date
June 17 2020
End Date
December 2 2022
Last Update
November 29 2024
Active Locations (12)
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1
Institut Jules Bordet
Brussels, Belgium
2
UCL St-Luc
Brussels, Belgium
3
University Hospital Antwerp (UZA)
Edegem, Belgium
4
Universitair Ziekenhus Gent
Ghent, Belgium