A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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. VMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver/HCC tumor models and preclinical toxicology and pharmacology studies support this study.
Sponsor: VM Discovery, Inc.
You may qualify if…
- ✓ 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 intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.
- ✓ 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 treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.
- ✓ 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
You may not qualify if…
- ✕ 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 by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.
- ✕ 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 jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.
- ✕ 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.
Where it's recruiting
Scottsdale
Source: ClinicalTrials.gov · NCT07636785 · last updated 2026-08-19