Advanced Malignant Solid Tumor, Solid Tumor Cancer
Conditions
Keywords
Gastrointestinal cancer, Liver metastases, Bladder cancer, Liver cancer, Phase 1, Dose escalation, Advanced solid tumors, cholangiocarcinoma, colorectal liver metastases
Brief summary
The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are: What adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug). Participants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment. For the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.
Detailed description
This study is a phase 1, open label, dose escalation and dose expansion study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.
Interventions
DRUGPLT012
PLT012 (anti-CD36 monoclonal antibody)
Sponsors
Pilatus Biosciences Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged at least 18 years and provided written informed consent * Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies) * Has at least one measurable lesion per RECIST v1.1 * ECOG PS of 0 to 1 * Life expectancy of ≥ 12 weeks * Child-Pugh score of Class A (for hepatocellular carcinoma only) * Adequate organ function as defined by protocol-specified laboratory values * Not pregnant or breastfeeding
Exclusion criteria
* Insufficient washout period from prior therapies as defined in the study protocol * Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions) * Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions) * Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections * Unstable/uncontrolled or untreated central nervous system (CNS) metastasis * Active or recent (within 3 years) autoimmune disease requiring medical treatment * Recipient of any organ transplant including allogeneic stem-cell transplant * Clinically significant and active cardiovascular disease * Known active alcohol or drug abuse * Psychiatric disorders that would prohibit the understanding of the Informed Consent Form * Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency, type and severity of dose limiting toxicities and adverse events | 18 months | Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Properties of PLT012 | 18 months | Plasma concentration of PLT012 at each timepoint at different dose levels |
| Immunogenicity of PLT012 | 18 months | Percentage and titer of the anti-drug antibody (ADA) at different dose levels of PLT012 |
| Preliminary efficacy of PLT012 | 18 months | Clinical activity as evidenced by Overall Response Rate (ORR) |
Countries
United States
Contacts
CONTACTNovotech Project Manager
PRINCIPAL_INVESTIGATORAnthony El-Khoueiry, MD
University of Southern California
Outcome results
None listed