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PD-1 Inhibitor
LYT-200 + Chemotherapy/Tislelizumab for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by PureTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have received at least one prior line of systemic therapy for metastatic or locally advanced disease, and/or have a tumor type for which there are no available standard of care options
ECOG performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, LYT-200, for safety and effectiveness in treating patients with metastatic solid tumors.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions to immunotherapies such as fatigue, skin reactions, digestive issues; specific side effects of LYT-200 are not detailed but may align with common chemotherapy or immunotherapy-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had at least one treatment for my advanced cancer or have a cancer with no standard treatment options.
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I am fully active or can carry out light work.
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I am willing and able to have biopsies before, during, and after treatment.
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I am 18 years or older and not pregnant.
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My cancer cannot be removed by surgery and has spread.
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My cancer is advanced and cannot be removed by surgery, and I've had various treatments.
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I have never been treated with gemcitabine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Incidence of Dose Limiting Toxicities [Tolerability]
Part 1: Incidence of Treatment-Emergent Adverse Events [Safety]
Part 2: PFS or ORR [Preliminary Efficacy]
Secondary outcome measures
Part 1: Pharmacodynamics (PD) of LYT- 200
Part 1: Pharmacokinetic (PK) profile of LYT-200: Area Under the Curve [AUC]
Part 1: Pharmacokinetic (PK) profile of LYT-200: Maximum Plasma Concentration [Cmax]
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment3 Interventions
LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1
Group II: Part 1 single agent dose escalationExperimental Treatment1 Intervention
LYT-200 in metastatic solid tumors
Group III: Part 1 combination agents dose expansionExperimental Treatment3 Interventions
LYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
PureTechLead Sponsor
5 Previous Clinical Trials
751 Total Patients Enrolled
Aleksandra Filipovic, MD, Ph.D.Study DirectorPureTech Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing serious bleeding issues.I've had at least one treatment for my advanced cancer or have a cancer with no standard treatment options.My cancer has spread, but the original cancer site is unknown.I am willing and able to follow the study's requirements.I have had serious blood vessel problems recently.I am fully active or can carry out light work.I still have high calcium levels despite taking bisphosphonates.I need frequent procedures to remove fluid from my chest, heart area, or abdomen.I don't have any health issues that could affect the trial's results.I am currently receiving dialysis.I have waited the required time since my last cancer treatment before starting LYT-200.My cancer can be measured by standard criteria and hasn't been biopsied yet.My cancer type has been confirmed by specific lab tests.I am willing and able to have biopsies before, during, and after treatment.I've had immune-related side effects from previous cancer immunotherapy.I have another cancer that needs active treatment.I have active brain metastases or cancer spread to the linings of the brain.I do not have severe illnesses or heart issues that would make joining the trial unsafe.I have an autoimmune disorder and need treatment to suppress my immune system.I do not have any health conditions that would make it unsafe for me to take a new drug.My blood and organ tests meet the required health standards.I have severe cancer pain that hasn't improved with pain medication.I have had radiation therapy recently, but only for symptom relief in a small area.I have been on bisphosphonate treatment before this clinical trial.I understand the study details and am willing to sign the consent form.I have a serious wound, ulcer, or bone fracture that is not healing.I am 18 years or older and not pregnant.My cancer cannot be removed by surgery and has spread.I do not use illegal drugs, but I may use marijuana, CBD, or THC.I am willing and able to have biopsies before, during, and after treatment.My cancer is advanced and cannot be removed by surgery, and I've had various treatments.I'm sorry, I cannot provide a summary without further information on what "Part 1" and "Part 2" refer to. Please provide more context.I have received an organ transplant.I am not currently in a clinical trial or taking experimental drugs for solid tumors.I have previously received immunotherapy.Your disease can be measured using a specific set of guidelines called RECIST v1.1.I have had a pulmonary embolism, stroke, or TIA recently.I have a specific type of tumor.My liver function meets specific health criteria.You have had serious allergic reactions to certain types of medications made from human or animal proteins.I have never been treated with gemcitabine.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 combination agents dose expansion
- Group 2: Part 2
- Group 3: Part 1 single agent dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
How old are they?
65+
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
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