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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
Must not have
Clinically significant, active uncontrolled bleeding, and any patients with a bleeding diathesis
Patient diagnosed with metastatic cancer of an unknown primary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing serious bleeding issues.
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My cancer has spread, but the original cancer site is unknown.
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I have had serious blood vessel problems recently.
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I still have high calcium levels despite taking bisphosphonates.
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I need frequent procedures to remove fluid from my chest, heart area, or abdomen.
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I am currently receiving dialysis.
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I've had immune-related side effects from previous cancer immunotherapy.
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I have another cancer that needs active treatment.
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I have active brain metastases or cancer spread to the linings of the brain.
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I have an autoimmune disorder and need treatment to suppress my immune system.
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I have severe cancer pain that hasn't improved with pain medication.
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I have a serious wound, ulcer, or bone fracture that is not healing.
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I have received an organ transplant.
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I have had a pulmonary embolism, stroke, or TIA recently.
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I have a specific type of tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
~4700

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

Anti-PD-1 (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04666688 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Part 1 combination agents dose expansion, Part 2, Part 1 single agent dose escalation
Pancreatic Cancer Clinical Trial 2023: Anti-PD-1 Highlights & Side Effects. Trial Name: NCT04666688 — Phase 1 & 2
Anti-PD-1 (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666688 — Phase 1 & 2
~16 spots leftby Nov 2025
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