LYT-200 + Chemotherapy/Tislelizumab for Cancer

Recruiting at 15 trial locations

Overseen By Aleksandra Filipovic, MD, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: PureTech

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Brain metastases, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors

Research Team

Aleksandra Filipovic, MD, Ph.D.

Principal Investigator

PureTech Health

Eligibility Criteria

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

I've had at least one treatment for my advanced cancer or have a cancer with no standard treatment options.

I am fully active or can carry out light work.

Negative pregnancy test and agreement to contraceptive methods for women of childbearing potential

Exclusion Criteria

I do not have any ongoing serious bleeding issues.

My cancer has spread, but the original cancer site is unknown.

I am willing and able to follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

approximately 1 year

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

approximately 1 year

Dose Expansion Phase

Dose expansion in single agent or combination based on the recommended Phase 2 dose determined in Part 1

approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Part 2 Experimental Treatment 3 Interventions

LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1

Group II: Part 1 single agent dose escalation Experimental Treatment 1 Intervention

LYT-200 in metastatic solid tumors

Group III: Part 1 combination agents dose expansion Experimental Treatment 3 Interventions

LYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors

Who Is Running the Clinical Trial?

PureTech

Lead Sponsor

Trials

7

Recruited

830+