LYT-200 + Chemotherapy/Tislelizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a drug called LYT-200, both alone and in combination with chemotherapy or Tislelizumab (an anti-PD-1 therapy), for treating metastatic solid tumors. The trial divides into different parts to assess the treatments' effectiveness and how the body processes them. It suits individuals with advanced or metastatic cancer who have not found success with other treatments. Participants should be willing and able to undergo medical evaluations and provide tissue samples for research. As a Phase 1/Phase 2 trial, this research aims to understand how LYT-200 works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have received anticancer treatment within the last 7 days before starting the study drug, and there should be a gap of four weeks or 5 half-lives since the last dose of any anticancer therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LYT-200 is generally safe. In earlier studies, participants tolerated this treatment well, with some experiencing tumor shrinkage. When combined with chemotherapy drugs like gemcitabine and nab-paclitaxel, the safety results remained positive. These chemotherapy drugs are already known to be safe for treating certain cancers.
LYT-200 also demonstrated good safety levels when combined with Tislelizumab, a treatment that aids the immune system in fighting cancer. This combination has been closely monitored, and early results suggest it is well-tolerated.
Overall, treatments in this trial have shown promising safety results in earlier studies. While joining a trial always involves some risk, evidence suggests these treatments are generally safe for patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about LYT-200 because it targets the Galectin-9 protein, which is known to help cancer cells evade the immune system. Unlike standard treatments that primarily focus on directly attacking cancer cells, LYT-200 boosts the body's immune response, potentially offering a new way to combat cancer. Additionally, when combined with chemotherapy or Tislelizumab, an anti-PD-1 therapy that further enhances immune system activity, LYT-200 may provide a more comprehensive approach to treating metastatic solid tumors. This combination strategy could lead to better outcomes by attacking the cancer on multiple fronts.
What evidence suggests that this trial's treatments could be effective for metastatic solid tumors?
Studies have shown that LYT-200, a type of antibody, holds promise in controlling disease and shows initial effectiveness in treating solid tumors. Research in animals found that LYT-200 significantly slowed tumor growth and extended the animals' lifespan. This trial tests LYT-200 both as a single agent and in combination with other treatments. Tislelizumab, a therapy that aids the immune system in fighting cancer, has improved response rates in patients with certain advanced cancers. Specifically, it significantly improved survival rates when combined with chemotherapy for advanced nasopharyngeal cancer. In this trial, Tislelizumab is tested in combination with LYT-200 to determine if they offer additional benefits for patients with advanced solid tumors.12356
Who Is on the Research Team?
Aleksandra Filipovic, MD, Ph.D.
Principal Investigator
PureTech Health
Are You a Good Fit for This Trial?
Adults with certain advanced cancers (like head and neck, pancreatic, bladder, or colorectal) that can't be removed by surgery. They should have measurable disease and be able to undergo biopsies. Prior immunotherapy is okay if they meet response criteria. Must not be pregnant and agree to contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation Phase - Single Agent
A dose-finding study using a continuous reassessment method to establish dose-limiting toxicities and the recommended Phase 2 dose
Dose Escalation Phase - Combination
A dose-finding combination study with chemotherapy or tislelizumab using a 4+2 study design to establish dose-limiting toxicities and the recommended Phase 2 dose
Dose Expansion Phase
Dose expansion in single agent or combination based on the recommended Phase 2 dose determined in Part 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anti-PD-1
- Gemcitabine/nab-paclitaxel
- LYT-200
- Tislelizumab
Trial Overview
The trial tests LYT-200 alone or combined with chemotherapy or Tislelizumab in patients with metastatic solid tumors. It's an early-phase study assessing safety, how the body processes the drugs, and their effectiveness against cancer.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1
LYT-200 in metastatic solid tumors
LYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
PureTech
Lead Sponsor
Citations
LYT-200
LYT-200 demonstrated a favorable safety profile in all cohorts and showed disease control and initial efficacy signals. The LYT-200 solid tumor study enrolled ...
LYT-200 Alone and in Combination With Chemotherapy or ...
LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1. Intervention/Treatment, Drug : LYT-200. monoclonal antibody ...
LYT-200 Gains FDA Fast Track Status in Acute Myeloid ...
The FDA has granted LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, fast track designation for the potential treatment of patients with AML.
4.
onclive.com
onclive.com/view/fda-fast-track-designation-granted-to-lyt-200-in-recurrent-metastatic-hnsccFDA Grants Fast Track Designation to LYT-200 ... - OncLive
Initial data from this trial were presented at the 2023 ESMO Immuno-Oncology Congress and demonstrated a favorable safety/tolerability profile ...
482 Phase1/2 study of an anti-galectin-9 antibody, LYT- ...
In murine models of melanoma and pancreatic cancer, LYT-200 significantly reduced tumor growth, extended survival and modulated the intra- ...
6.
news.puretechhealth.com
news.puretechhealth.com/news-releases/news-release-details/puretech-presents-data-lyt-200-anti-galectin-9-monoclonalPureTech Presents Data for LYT-200 (anti-galectin-9 ...
Out of 15 evaluable patients who received combination therapy, 80% achieved stable disease or better, with two experiencing complete responses ...
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