Pilatus Biosciences to Present Phase 1 PLT012 Clinical Trial at ESMO Congress 2026
Pilatus Biosciences, a biopharmaceutical company focused on developing novel metabolic checkpoint immunotherapies for cancer, announced that its ongoing Phase 1 clinical trial of PLT012 has been selected for a Trials-in-Progress poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026. The international oncology meeting will take place October 23–27, 2026, in Madrid, Spain.
PLT012 is described by Pilatus Biosciences as a first-in-class monoclonal antibody targeting CD36, a key fatty acid transporter involved in lipid uptake. The company is developing the investigational therapy as a potential approach to addressing metabolic mechanisms that contribute to immune suppression within the tumor microenvironment.
The upcoming ESMO presentation will provide an overview of the design and objectives of the ongoing first-in-human Phase 1 study, which is evaluating PLT012 in adults with advanced solid tumors. The trial is intended to establish the safety and tolerability profile of the investigational antibody while also generating early information on its pharmacological and potential antitumor activity.
PLT012 Targets a Metabolic Mechanism in the Tumor Microenvironment
Cancer immunotherapy has transformed the treatment landscape for several tumor types, but many patients either fail to respond to currently available immune-based treatments or eventually develop resistance. Tumors can create a highly immunosuppressive microenvironment through multiple mechanisms, including metabolic changes that interfere with the ability of immune cells to mount effective antitumor responses.
Pilatus Biosciences is investigating CD36 as one such metabolic checkpoint. CD36 functions as a fatty acid transporter and is involved in the uptake of lipids by cells. According to the company, tumor-associated immune cells can use lipid uptake pathways that contribute to an immunosuppressive environment around tumors.
PLT012 is designed to block CD36-mediated lipid uptake. By inhibiting this pathway, the company aims to reduce metabolically driven immune suppression and potentially support antitumor immune activity.
The approach represents a strategy that differs from conventional immune checkpoint inhibition, which primarily targets signaling pathways that regulate immune-cell activation. Instead, PLT012 is being developed to intervene in a metabolic pathway that may influence immune-cell behavior within the tumor microenvironment.
“Despite major advances in immuno-oncology, treatment resistance remains a significant challenge, particularly in tumors that have historically been difficult to treat with existing immunotherapies,” said Raven Lin, Ph.D., co-founder and CEO of Pilatus Biosciences.
According to Lin, PLT012 is intended to address metabolic mechanisms that tumors exploit to suppress immune responses. The company plans to use the Phase 1 study to investigate whether this first-in-class approach can be translated into clinical activity in patients with advanced solid tumors.
Preclinical Findings Support Clinical Development
Before entering human clinical testing, PLT012 was evaluated in spontaneous and orthotopic tumor models. Pilatus Biosciences reported potent efficacy across several tumor types characterized as cold or difficult-to-treat malignancies.
The preclinical program included models of hepatocellular carcinoma (HCC), colorectal liver metastasis (CRLM), muscle-invasive bladder cancer, intrahepatic cholangiocarcinoma (iCCA) and colorectal cancer (CRC).
These tumor types represent areas where the tumor microenvironment and treatment resistance can present significant challenges for existing therapeutic approaches. The findings from the company’s preclinical research provided the rationale for advancing PLT012 into clinical development in patients with advanced solid tumors.
The company is now evaluating whether the biological effects observed in preclinical studies can be reproduced in humans and whether CD36 inhibition can generate measurable antitumor effects.
Because PLT012 remains investigational, the results from preclinical models cannot establish clinical efficacy or safety in patients. The ongoing Phase 1 trial is therefore focused primarily on determining an appropriate dose and establishing the safety profile of the therapy.
Phase 1 Trial Evaluates Safety and Preliminary Efficacy
The ongoing first-in-human Phase 1 study is an open-label, multicenter clinical trial enrolling adults with advanced solid tumors. Participants are heavily pre-treated, intolerant of available standard therapies or not candidates for currently available standard treatment options.
The study uses a dose-escalation design incorporating the Bayesian Optimal Interval (BOIN) methodology. Under the protocol, sequential dose levels of PLT012 are administered intravenously once every three weeks.
Dose escalation is intended to help investigators determine how patients tolerate increasing levels of the investigational antibody and identify a dose range suitable for further clinical development.
The study also incorporates additional cohorts designed to investigate PLT012 in specific disease settings. These include hepatocellular carcinoma biomarker backfill cohorts and planned tumor-specific expansion cohorts in HCC, CRLM and iCCA.
The incorporation of biomarker and tumor-specific cohorts is intended to provide additional information about the biological activity of PLT012 and potentially identify tumor populations that could be suitable for subsequent clinical development.
Multiple Clinical Objectives Included in Study
The primary objectives of the Phase 1 trial center on establishing the safety and tolerability of PLT012.
Investigators will assess dose-limiting toxicities and adverse events while determining the maximum tolerated dose and/or recommended Phase 2 dose. These assessments are important components of early-stage clinical development because they help establish the appropriate dose and schedule for later-stage studies.
Beyond safety, the study includes secondary and exploratory assessments designed to characterize potential antitumor activity and the pharmacological behavior of PLT012.
Efficacy-related measures include objective response rate, duration of response, time to response, disease control rate, progression-free survival and overall survival. These endpoints will provide preliminary information about how tumors respond to treatment and how long any observed responses or disease control may persist.
The trial will also evaluate pharmacokinetics to understand how PLT012 behaves in the body. Additional assessments include anti-drug antibody testing and pharmacodynamic analyses, which may help investigators understand the biological effects of CD36 blockade and the body’s response to the investigational antibody.
Because the study is in its Phase 1 stage, these efficacy assessments are exploratory and are not designed to provide definitive evidence of clinical benefit.
ESMO 2026 Trials-in-Progress Presentation
Pilatus Biosciences will present the design and ongoing status of the clinical program during the ESMO Congress 2026.
The presentation is titled “A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of PLT012 in Participants with Advanced Solid Tumors.”
The presentation number is 2012TiP. Anthony B. El-Khoueiry, M.D., will serve as the presenter.
The presentation is scheduled for Saturday, October 24, 2026, from 12:00 to 12:45 p.m. in Madrid.
El-Khoueiry is associate director for clinical research and chief of the Section of Developmental Therapeutics at USC Norris Comprehensive Cancer Center. He is also an associate professor of clinical medicine at the Keck School of Medicine of USC.
According to El-Khoueiry, CD36 represents a novel potential target for addressing metabolic mechanisms within the tumor microenvironment.
“Targeting CD36 represents a novel approach to addressing the immunosuppressive tumor microenvironment by disrupting the metabolic pathways that tumors use to evade immune responses,” El-Khoueiry said.
He also highlighted the importance of the HCC biomarker backfill and planned tumor-specific expansion cohorts as the study advances.
These cohorts will help investigators examine whether the biological consequences of CD36 blockade can translate into clinically meaningful activity. El-Khoueiry emphasized that the findings remain preliminary and that the study is being conducted using an evidence-driven approach as additional clinical information becomes available.
Evaluating a New Metabolic Checkpoint Strategy
The Phase 1 development of PLT012 represents Pilatus Biosciences’ broader effort to investigate metabolic mechanisms involved in cancer immunity.
Rather than focusing exclusively on conventional immune signaling checkpoints, the company is exploring whether altering lipid metabolism in tumor-associated immune cells can change the immunosuppressive conditions surrounding tumors.
The clinical program will provide initial human data needed to determine whether the CD36-targeting strategy is safe, tolerable and biologically active. Results from dose escalation and the subsequent biomarker and tumor-specific cohorts could help guide decisions regarding future development of PLT012.
For patients with advanced solid tumors who have limited treatment options, new therapeutic strategies remain an important area of oncology research. However, the potential clinical value of PLT012 will depend on findings from its ongoing clinical studies.
The ESMO Congress 2026 presentation will therefore represent an important opportunity for the company and investigators to outline the study design, patient population, dosing strategy and planned assessments as clinical evaluation continues.
As the Phase 1 trial progresses, safety findings, pharmacokinetic and pharmacodynamic data, biomarker analyses and preliminary measures of antitumor activity will provide the foundation for determining whether PLT012 can advance into later-stage clinical development.
About PLT012
PLT012 is the lead investigational therapy from Pilatus Biosciences’ first-in-class CD36 metabolic checkpoint platform. The humanized IgG4 monoclonal antibody selectively blocks CD36, a key regulator of lipid metabolism, inflammation and tissue repair. PLT012 is currently being evaluated in an ongoing Phase 1 oncology clinical trial, where it has demonstrated early evidence of disease control together with a favorable safety profile. In preclinical studies, PLT012 has demonstrated disease-modifying activity across oncology, MASH and COPD, supporting Pilatus’ Pipeline-in-a-Product strategy to develop a single differentiated mechanism across multiple high-unmet-need indications.
About Pilatus Biosciences
Pilatus Biosciences is a clinical-stage biopharmaceutical company pioneering metabolic checkpoint therapeutics for cancer and immune-related diseases. Founded in 2022 from the Ludwig Institute for Cancer Research, and supported by the Cancer Research Institute, Pilatus operates internationally with R&D teams in Switzerland, U.S, and Taiwan. The company’s lead program, PLT012, targets CD36 to reprogram the tumor microenvironment and restore anti-tumor immunity in solid tumors.