Phase I Study of RNA Oligonucleotide, MTL-CEBPA, Atezolizumab and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma.

Sponsor
National University Hospital, Singapore
Study ID
NCT05097911
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MTL-CEBPA — DRUG
    The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.
  • Atezolizumab — DRUG
    The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.
  • Bevacizumab — DRUG
    The starting dose will be at dose level 1. For cycle 1 only, there will be a lead-in period whereby patients will receive one dose of MTL-CEBPA, 7 days prior to cycle 1 day 1. MTL-CEBPA is then administered on Day 1 and 8 of each cycle, atezolizumab is administered on Day 1 of each cycle and bevacizumab is administered on Day 1 of each cycle. One cycle of treatment consists of 21 days.

Study Details

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.

Key Dates

Start date
Aug 2, 2021
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced HCC patients
    Patients will receive treatment as outlined until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status. If scheduled dosing and study assessments are precluded because of a holiday, weekend, or other event, then dosing may be postponed to the soonest following date, with subsequent dosing continuing on a 21-day schedule. If treatment was postponed for fewer than 3 days, the patient can resume the original schedule.

Primary Outcome Measure

Evaluable for Objective Response [ Time Frame: 5 years ]

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