NCT05698238

Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours

Phase Ib/ll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mabpro, a.s. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of \[18F\]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.

Conditions

• Clear Cell Renal Cell Carcinoma Metastatic
• TNBC - Triple-Negative Breast Cancer
• Head and Neck Cancer
• Non-small-cell Lung Carcinoma
• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	CA9hu-1	Humanized monoclonal antibody to human carbonic anhydrase IX

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2023-01-26
• Last updated: 2023-03-15