A Phase 1 Study of RNA Oligonucleotide, MTL-CEBPA, Atezolizumab and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma Without Previous Systemic Therapy.

NCT05097911 Phase 1 ACTIVE_NOT_RECRUITING

This is a single-center, phase 1, open label, dose-escalation study of MTL-CEBPA co-administered with atezolizumab and bevacizumab to assess the PK, PD, and potential toxicities of the drug combination in advanced HCC patients, and to determine the MTD, OBD or RP2D. The sample size employed is a minimally modified standard 3+3 cohort model commonly used in Phase I oncology studies. Once determined, the MTD/OBD/RP2D will be administered to an Expansion Cohort (Phase Ib) of 10 additional patients with advanced HCC.

Details

Lead sponsor	National University Hospital, Singapore
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	33
Start date	2021-08-02
Completion	2027-04

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

• MTL-CEBPA
• Atezolizumab
• Bevacizumab

Primary outcomes

• Evaluable for Objective Response — 5 years
  Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response (using RECIST v1.1)
• Evaluable Non-Target Disease Response — 5 years
  Patients who have lesions present at baseline that are evaluable but do not meet the definitions of measurable disease, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for non-target lesion assessment. The response assessment is based on the presence, absence, or unequivocal progression of the lesions.

Countries

Singapore