Advanced Malignant Solid TumorPhase 1NCT07337525
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
A Phase 1 study testing PLT012 in people with Advanced Malignant Solid Tumor and Solid Tumor Cancer, run by Pilatus Biosciences Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumor, Solid Tumor Cancer
- What is being tested?
- PLT012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Feb 2026to Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
NEXT Dallas
Dallas, Texas, 75039
Mofopefoluwa Akinwale, 972-893-8800, fakinwale@nextoncology.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Administrator, Division of Clinical Research, 713-745-7139, cacartwr@mdanderson.org
Apostolia Tsimberidou
- Recruiting
NEXT Houston
Houston, Texas, 77054
Emma Morales, 832-384-7912, emorales@nextoncology.com
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Clinical Investigations Support Office, 323-865-0240, stephanie.kim2@med.usc.edu
Anthony El-Khoueiry
About this study
Official title: A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
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).
Read more
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.
Read the 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.
- Conditions
- Advanced Malignant Solid Tumor, Solid Tumor Cancer
- Being tested
- PLT012
- Keywords
- Gastrointestinal cancer, Liver metastases, Bladder cancer, Liver cancer, Phase 1, Dose escalation, Advanced solid tumors, cholangiocarcinoma, colorectal liver metastases
- Medical subject headings
- Gastrointestinal Neoplasms, Urinary Bladder Neoplasms, Liver Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLT012Drug
PLT012 (anti-CD36 monoclonal antibody)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: PLT012 | Experimental | PLT012 administered via intravenous infusion once every 3 weeks Receives: Drug: PLT012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, type and severity of dose limiting toxicities and adverse events
Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0
Measured: 18 months
Secondary outcomes (8)
Pharmacokinetic Properties of PLT012
Plasma concentration of PLT012 at each timepoint at different dose levels
Measured: 18 months
Immunogenicity of PLT012
Percentage and titer of the anti-drug antibody (ADA) at different dose levels of PLT012
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by Overall Response Rate (ORR)
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by disease control rate (DCR)
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by time to response (TTR)
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by duration of response (DOR)
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by progression-free survival (PFS)
Measured: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by overall survival (OS)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start13 Feb 2026
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pilatus Biosciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony El-Khoueiry, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337525
- Sponsor's protocol ID
- PLT012-P1-001
- Status last verified
- Jul 2026
- First submitted
- 2 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pilatus will likely provide this data, but need to formalize the plan first.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07337525
- Acronym / sponsor ID
- PLT012-P1-001
- Conditions
- Advanced Malignant Solid Tumor, Solid Tumor Cancer
- Keywords
- Gastrointestinal cancer, Liver metastases, Bladder cancer, Liver cancer, Phase 1, Dose escalation, Advanced solid tumors, cholangiocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pilatus Biosciences IncIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: PLT012 | Experimental | Drug: PLT012PLT012 administered via intravenous infusion once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLT012PLT012 (anti-CD36 monoclonal antibody) | Drug | Experimental Arm: PLT012 |
Primary outcome
Frequency, type and severity of dose limiting toxicities and adverse events
Time frame: 18 months
Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0
8 secondary outcomes
Pharmacokinetic Properties of PLT012
Time frame: 18 months
Immunogenicity of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided. Pilatus will likely provide this data, but need to formalize the plan first.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony El-Khoueiry, MD principal investigator
University of Southern California
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLT012 in people with Advanced Malignant Solid Tumor and Solid Tumor Cancer, run by Pilatus Biosciences Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novotech Project Manager (+1 843 203 1031, Madison.Daniels@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, type and severity of dose limiting toxicities and adverse events (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.