To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
NCT ID:
NCT06478693
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Liver Cancer
Hepatocellular Carcinoma (HCC)
Glypican-3
Chimeric antigen receptor
CAR-M
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MT-303
Description:
MT-303
Arm group label:
MT-303
Summary:
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study
designed to assess the safety, tolerability and define the RP2D of MT-303 in participants
with advanced hepatocellular carcinoma expressing GPC3.
Detailed description:
MT-303 will be administered intravenously with treatment provided until lack of
tolerability or progression. Participants will be enrolled in sequential dose escalation
cohorts with determination of dose limiting toxicities with the goal of establishing the
(maximum tolerated dose) MTD and (Recommended Phase 2 dose) RP2D.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Aged 18 years or older
- Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC.
[Note: participants with other tumor types expressing GPC3 may be eligible pending a
discussion with the Medical Monitor]
- Measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Child-Pugh score: Class A
- Adequate organ function
Exclusion Criteria
- Known active central nervous system (CNS) metastasis and/or carcinomatous
meningitis.
- Any acute illness including active infection
- History of liver transplantation or on waiting list
- Participants with untreated or incompletely treated varices with bleeding or high
risk for bleeding
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- History of symptomatic congestive heart failure
- History of chronic or recurrent (within the last year) severe autoimmune or immune
mediated disease requiring steroids or other immune-suppressive treatments.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Vincent's Hospital
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Hao-Wen Sim, MD
Facility:
Name:
Integrated Clinical Oncology Network (ICON) Pty Ltd
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Vladimir Andelkovic, MD
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Stuart Roberts, MD
Facility:
Name:
Linear Clinical Research
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Tim Humphries, MD
Start date:
July 1, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Myeloid Therapeutics
Agency class:
Industry
Source:
Myeloid Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478693
