Clinical trial for Hepatocellular Carcinoma (HCC)
Official title A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT07636785
What this study is testing
What is VMD-102?
VMD-102 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Also referred to as Single agent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histological or cytological or radiological diagnosis of advanced (unresectable and/or metastatic) HCC, MUM, RCC, NSCLC and CRC that is not...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.
- Has at least one measurable target lesion according to RECIST v1.1 [Response Evaluation Criteria In Solid Tumors], or mRECIST [modified RECIST] for...
- Adequate organ function evidenced by: Hematology
- Hemoglobin ≥ 9 g/dL (SI Units: 90 g/L) (post-transfusion if transfusion-dependent)
You likely can't join if
- Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or tumor embolization within the past 2 weeks or 5 half-lives...
- Currently pregnant, nursing, or planning to become pregnant during the course of study.
- The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence...
- Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment...
- Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the...
See the full eligibility criteria
Who can join
- Histological or cytological or radiological diagnosis of advanced (unresectable and/or metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.
- Has at least one measurable target lesion according to RECIST v1.1 [Response Evaluation Criteria In Solid Tumors], or mRECIST [modified RECIST] for unresectable HCC participants, and either (a). has not been previously...
- Adequate organ function evidenced by: Hematology
- Hemoglobin ≥ 9 g/dL (SI Units: 90 g/L) (post-transfusion if transfusion-dependent)
- Platelet count ≥ 60000/mm3 (60 x109/L) without support(transfusion) within 7 days of testing
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (1.5x109/L) Chemistry
- Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \<30% of the TBIL)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)
- AST and/or ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)
- Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL/min using Cockroft-Gault formula.
- Serum creatinine ≤ 1.5x ULN Coagulation (unless taking an anti-coagulant):
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)
- International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants
- Albumin ≥2.8g/d/L.
- For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer...
- Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with...
- Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening)...
- Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and...
- Participant has a life expectancy of ≥3 months.
- No history of liver transplantation.
- Ability to swallow and absorb an orally self-administered medication in tablet form.
- Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before...
- Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or...
What rules you out
- Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).
- Currently pregnant, nursing, or planning to become pregnant during the course of study.
- The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed...
- Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.
- Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise...
- Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).
- Participants have long-term unhealed wounds or fractures.
- Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
- Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:
- Severe uncontrolled nausea or vomiting.
- Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).
- A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs/symptoms or require medications.
- Clinically diagnosed malabsorption secondary to bowel resection.
- Active Ulcerative colitis or Crohn's disease requiring medication for control.
- Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.
- Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior...
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.
- Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \>100 IU/mL. Participants on active HBV therapy with viral loads \<100 IU/mL should stay on the same therapy throughout...
- Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease
- HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed...
- History of allogeneic tissue/organ transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).
- Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.
- Participants with active alcohol and/or substances abuse, Phosphatidylethanol (Peth) must be \<50 ng/mL).
- Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors...
- Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a...
- Participants have long-term unhealed wounds or fractures.
- Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.
- Known history of uncontrolled human immunodeficiency virus (HIV) infection.
- Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.