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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

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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

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

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 more

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

~4260

0 / 22Eligibility criteria met

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

Head and Neck Cancers Research Study Groups: Part 1 combination agents dose expansion, Part 2, Part 1 single agent dose escalation

Head and Neck Cancers 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

~2 spots leftby Sep 2024

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