Metastatic CancerPhase 1/2NCT04666688
LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing LYT-200, Tislelizumab and Gemcitabine/nab-paclitaxel in people with Metastatic Cancer and Solid Tumor, run by PureTech at 12 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Solid Tumor, Pancreatic Cancer
- What is being tested?
- LYT-200, Tislelizumab and Gemcitabine/nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Dec 2020to 12 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1
- Written Informed Consent (mentally competent patient, able to understand and willing to sign the informed consent form)
- Age ≥ 18 years, male or non-pregnant female
- Able to comply with the study protocol, as per Investigator's judgment
- Histologically confirmed, unresectable locally advanced or metastatic cancer. There are no limits to prior lines of therapies received for the treatment of the cancer condition for which the patient is being enrolled into this study.
- For the Part 1 combination urothelial carcinoma Cohorts 13 and 14: histologically or cytologically confirmed diagnosis of unresectable, locally advanced or metastatic urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (i.e., transitional cell carcinoma).
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- For the Part 1 combination H/N cancer Cohorts 11 and 12: histologically confirmed, locally advanced or metastatic squamous cell carcinoma of head and neck (SCCHN; oral cavity, oropharynx, hypopharynx, or larynx).
- For urothelial and H/N combination cancer cohorts, prior exposure to immunotherapy is allowed, with standard of care treatment options and/or within a clinical trial context. If the patient received an anti-PD-1 and/or an anti-PD-L1 containing regimen at any point, they must have demonstrated at least stable disease, as per RECIST 1.1 or iRECIST criteria to one of these treatment regimens, if these measurements are available. If RECIST or iRECIST measurements are not available, then clinical PFS of at least 4 months is required to have been achieved on any of the prior anti-PD-1 and/or anti-PD-L1 containing regimens.
- There is no PD-L1 expression requirement for the Part 1 combination urothelial and H/N cohorts; however, fresh biopsy or archival tissue is required for assessment of PD-L1 by IHC, or a historical PD-L1 expression by IHC must be available. If PD-L1 expression data are already available, this does not override the protocol preference for obtaining a fresh biopsy whenever feasible.
- For Part 1 combination cohort H/N cancer patients of oropharynx origin: human papilloma virus (HPV) status needs to be established in the screening period or at any point while patient is on study drug, unless it is historically known. p16+ as a surrogate for HPV+, HPV RNA ISH or DNA PCR are all acceptable. The study accepts both HPV+ and HPV- patients.
- Life expectancy > 3 months according to Investigator's judgment
- ECOG performance status 0-1
- Patient able and willing to undergo pre- and on/post treatment biopsies. According to the Investigator's judgment, the planned biopsies should not expose the patient to substantially increased risk of complications. Every effort will be made that the same lesion is biopsied on repeat biopsies. If the patient is eligible according to all other criteria but declines to consent to a biopsy or there are other medical reasons precluding biopsy, this will be discussed with the Sponsor.
- Measurable disease, according to RECIST v1.1. Note that lesions intended to be biopsied should not be target lesions.
- Adequate hematologic and end organ function, defined by the following laboratory results obtained prior to first dose of study drug treatment, provided no anticancer treatment was administered within the last 7 days:
- neutrophil count ≥ 1 x 109/L
- platelet count ≥ 100 x 109/L; for hepatocellular carcinoma (HCC) in Part 1 ≥ 50 x 109/L
- hemoglobin ≥ 9.0 g/dL without transfusion in the previous week
- creatinine ≤ 1.5 x the upper limit of normal (ULN); or eGFR > 50 mg/mmol
- aspartate aminotransferase AST (SGOT) ≤ 3 x ULN (≤ 5 x ULN when HCC or hepatic metastases are present)
- alanine aminotransferase (ALT [SGPT]) ≤ 3 x ULN (≤ 5 x ULN when HCC or hepatic metastases present)
- bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease may have a bilirubin ≤ 3.0 x ULN)
- albumin ≥ 3.0 g/dL
- international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN, unless patient receiving anticoagulant therapy
- No evidence of active serious infection or infections requiring parenteral antibiotics.
- Women of childbearing potential must have a negative pregnancy test within 72 h prior to start of treatment. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last study treatment.
- A woman is of childbearing potential if she is post-menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception. Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- Four (4) weeks or 5 half-lives (whichever is shorter) since the last dose of anticancer therapy before the first LYT-200 administration
- Bisphosphonate treatment (e.g., zoledronic acid) or denosumab are allowed if previously used prior to commencement of clinical trial.
- Patients:
- who have already received at least one prior line of systemic therapy for metastatic or locally advanced disease, and/or
- who have a tumor type for which there are no available standard of care options
- Patients who have not previously received a gemcitabine-containing regimen
Who cannot join
- Patient unwilling or unable to follow protocol requirements
- Patient diagnosed with metastatic cancer of an unknown primary
- Current illicit drug addiction (medical and recreational marijuana/cannabidiol [CBD]/ tetrahydrocannabinol [THC] would not be considered "illicit")
- Clinically significant, active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease). Prophylactic or therapeutic use of anticoagulants is allowed.
- Pregnant and/or lactating females
- Receiving any other investigational agents or participating in any other clinical trial involving another investigational agent for treatment of solid tumors within 3 weeks or 5 half-lives of the administered drug (whichever is shorter) prior to the first dose of study drug, or major surgery or planned surgery within 4 weeks of the first dose of study drug (this includes dental surgery).
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- Radiation therapy within 4 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass, and which does not jeopardize required measurable lesions for response assessment (RECIST v1.1).
- Patients with fungating tumor masses
- History or current evidence of any condition, therapy, any active infections, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
- Grade 4 immune-mediated toxicities with a prior checkpoint inhibitor. Grade 2 or Grade 3 pneumonitis or any other Grade 3 checkpoint inhibitor-related toxicity that led to immunotherapy treatment discontinuation. Low-grade (< Grade 3) toxicities, such as neuropathy from prior treatments, manageable electrolyte abnormalities and lymphopenia, alopecia and vitiligo are allowed.
- History of other prior or other concomitant malignancy that requires other active treatment.
- Active parenchymal brain metastases, patients with carcinomatous meningitis or leptomeningeal metastases. Patients with brain metastases are eligible provided they have shown clinically and radiographically stable disease for at least 4 weeks after definitive therapy and have not used steroids (> 10 mg/day of prednisone or equivalent) for at least 4 weeks prior to the first dose of study drug
- Evidence of severe or uncontrolled systemic diseases, congestive heart failure > New York Heart Association (NYHA) class 2, myocardial infarction (MI) within 6 months, or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial
- Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of LYT-200 toxicity assessment
- Serious non-healing wound, active ulcer, or untreated bone fracture unless for e.g., a rib fracture for (which does not elicit treatment)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. For the purposes of this study, "recurrent" is defined as ³ 3 drains in the last 30 days
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of Cycle 1, Day 1
- History of pulmonary embolism, stroke or transient ischemic attack within 3 months prior to Cycle 1, Day 1
- Active autoimmune disorder (except type I/II diabetes, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia areata).
- Requires systemic immunosuppressive treatment, including, but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents. Patients who have received or are receiving acute, low dose systemic immunosuppressant medications (e.g., ≤ 10 mg/day of prednisone or equivalent) may be enrolled. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy [e.g., ≤ 10 mg/day of prednisone equivalent] for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone), topical steroids, intranasal steroids, intra-articular, and ophthalmic steroids is allowed.
- Severe tumor-related pain (Grade 3, CTCAE v.5.0) unresponsive to broad analgesic interventions (oral and/or patches)
- Hypercalcemia (defined as ³ Grade 3, per CTCAE v 5.0) despite use of bisphosphonates
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk of treatment complications
- Received organ transplant(s)
- Patients undergoing dialysis
- For Part 1, hormonal androgen deprivation therapy is allowed to continue for patients with metastatic castration-resistant prostate cancer
- Any ablative therapy (Radio Frequency Ablation or Percutaneous Ethanol Injection) for HCC < 6 weeks prior trial entry
- Hepatic encephalopathy or severe liver adenoma
- Child-Pugh score ≥ 7
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Colorado Hospital
Denver, Colorado, 80045
Sarah Cannon Research Institute at Health One
Denver, Colorado, 80218
South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, 49546
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
UCLA
Los Angeles, California, 90095
Sarah Cannon Research Institute, Tennessee Oncology
Nashville, Tennessee, 37203
Columbia University
New York, New York, 10027
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Sarah Cannon Research Institute, Florida Cancer Specialists
Sarasota, Florida, 34232
About this study
Official title: A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
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
Read the detailed description
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors.
Part 1: Dose Escalation Phase_Single Agent A dose-finding study will be conducted using a continuous reassessment method (CRM) to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D).
Part 1: Dose Escalation Phase_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 4+2 study design to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D).
Part 2: The second part of the protocol will be a dose expansion in both/or either single agent or combination based on the RP2D determined in Part 1, in patients with metastatic/advanced solid tumors.
- Conditions
- Metastatic Cancer, Solid Tumor, Pancreatic Cancer, Urothelial Carcinoma, Head and Neck Cancer, Colorectal Cancer
- Being tested
- LYT-200, Tislelizumab, Gemcitabine/nab-paclitaxel
- Keywords
- Metastatic cancer, Solid tumors, Combination therapy, Pancreatic cancer, Colon cancer, Bile duct cancer, Urothelial Carcinoma, Head and Neck Cancer, Colorectal Cancer
- Medical subject headings
- Neoplasm Metastasis, Pancreatic Neoplasms, Carcinoma, Transitional Cell, Head and Neck Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYT-200Drug
monoclonal antibody (mAb), targeting galectin-9 protein
TislelizumabDrug
anti-PD-1 monoclonal antibody
Gemcitabine/nab-paclitaxelDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Part 1 single agent dose escalation | Experimental | LYT-200 in metastatic solid tumors Receives: Drug: LYT-200 |
| Part 1 combination agents dose expansion | Experimental | LYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors Receives: Drug: LYT-200; Drug: Tislelizumab; Drug: Gemcitabine/nab-paclitaxel |
| Part 2 | Experimental | LYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1 Receives: Drug: LYT-200; Drug: Tislelizumab; Drug: Gemcitabine/nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence of Treatment-Emergent Adverse Events [Safety]
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status.
Measured: approximately 1 year
Part 1: Incidence of Dose Limiting Toxicities [Tolerability]
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status
Measured: approximately 1 year
Part 2: PFS or ORR [Preliminary Efficacy]
PFS or ORR depending on tumor type
Measured: approximately 1 year
Secondary outcomes (4)
Part 1: Pharmacokinetic (PK) profile of LYT-200: Maximum Plasma Concentration [Cmax]
To characterize Cmax of LYT- 200
Measured: approximately 1 year
Part 1: Pharmacokinetic (PK) profile of LYT-200: Time to Maximum Plasma Concentraton [Tmax]
To characterize Tmax of LYT- 200
Measured: approximately 1 year
Part 1: Pharmacokinetic (PK) profile of LYT-200: Area Under the Curve [AUC]
To characterize AUC of LYT- 200
Measured: approximately 1 year
Part 1: Pharmacodynamics (PD) of LYT- 200
blood and tumor tissue sampling, cell and non-cell based, immunological and cancer related PD markers
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Dec 2020
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1/2, two part, open-label study, which will enroll Part 1 and Part 2 sequentially. Part 1 is a single agent dose escalation design utilizing a continuous reassessment method (CRM) and a combination portion using a 4+2 study design. Part 2 is dose expansion into specific disease indications based on outcomes from Part 1.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- PureTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aleksandra Filipovic, MD, Ph.D., Study director, PureTech Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666688
- Sponsor's protocol ID
- LYT-200-2020-01
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label, Multi-center Study of the Safety, Pharmacokinetics, and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04666688
- Acronym / sponsor ID
- LYT-200-2020-01
- Conditions
- Metastatic Cancer, Solid Tumor, Pancreatic Cancer, Urothelial Carcinoma, Head and Neck Cancer, Colorectal Cancer
- Keywords
- Metastatic cancer, Solid tumors, Combination therapy, Pancreatic cancer, Colon cancer, Bile duct cancer, Urothelial Carcinoma, Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PureTechIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors.
Part 1: Dose Escalation Phase_Single Agent A dose-finding study will be conducted using a continuous reassessment method (CRM) to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D).
Part 1: Dose Escalation Phase_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 4+2 study design to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D).
Part 2: The second part of the protocol will be a dose expansion in both/or either single agent or combination based on the RP2D determined in Part 1, in patients with metastatic/advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1/2, two part, open-label study, which will enroll Part 1 and Part 2 sequentially. Part 1 is a single agent dose escalation design utilizing a continuous reassessment method (CRM) and a combination portion using a 4+2 study design. Part 2 is dose expansion into specific disease indications based on outcomes from Part 1.
| Arm | Type | Receives |
|---|---|---|
| Part 1 single agent dose escalation | Experimental | Drug: LYT-200LYT-200 in metastatic solid tumors |
| Part 1 combination agents dose expansion | Experimental | Drug: LYT-200, Drug: Tislelizumab, Drug: Gemcitabine/nab-paclitaxelLYT-200 in combination with chemotherapy or Tislelizumab in select metastatic solid tumors |
| Part 2 | Experimental | Drug: LYT-200, Drug: Tislelizumab, Drug: Gemcitabine/nab-paclitaxelLYT-200 combination dose expansion in select metastatic solid tumors based on outcomes of Part 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Part 1
- Written Informed Consent (mentally competent patient, able to understand and willing to sign the informed consent form)
- Age ≥ 18 years, male or non-pregnant female
- Able to comply with the study protocol, as per Investigator's judgment
- Histologically confirmed, unresectable locally advanced or metastatic cancer. There are no limits to prior lines of therapies received for the treatment of the cancer condition for which the patient is being enrolled into this study.
Key exclusion criteria (30 listed)
- Patient unwilling or unable to follow protocol requirements
- Patient diagnosed with metastatic cancer of an unknown primary
- Current illicit drug addiction (medical and recreational marijuana/cannabidiol [CBD]/ tetrahydrocannabinol [THC] would not be considered "illicit")
- Clinically significant, active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease). Prophylactic or therapeutic use of anticoagulants is allowed.
- Pregnant and/or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYT-200monoclonal antibody (mAb), targeting galectin-9 protein | Drug | Part 1 combination agents dose expansion, Part 1 single agent dose escalation, Part 2 |
| Tislelizumabanti-PD-1 monoclonal antibody | Drug | Part 1 combination agents dose expansion, Part 2 |
| Gemcitabine/nab-paclitaxelchemotherapy | Drug | Part 1 combination agents dose expansion, Part 2 |
Primary outcome
Part 1: Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: approximately 1 year
Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status.
Part 1: Incidence of Dose Limiting Toxicities [Tolerability]
Time frame: approximately 1 year
Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status
Part 2: PFS or ORR [Preliminary Efficacy]
Time frame: approximately 1 year
PFS or ORR depending on tumor type
4 secondary outcomes
Part 1: Pharmacokinetic (PK) profile of LYT-200: Maximum Plasma Concentration [Cmax]
Time frame: approximately 1 year
Part 1: Pharmacokinetic (PK) profile of LYT-200: Time to Maximum Plasma Concentraton [Tmax]
Time frame: approximately 1 year
Part 1: Pharmacokinetic (PK) profile of LYT-200: Area Under the Curve [AUC]
Time frame: approximately 1 year
Part 1: Pharmacodynamics (PD) of LYT- 200
Time frame: approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Filipovic, MD, Ph.D. study director
PureTech Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LYT-200, Tislelizumab and Gemcitabine/nab-paclitaxel in people with Metastatic Cancer and Solid Tumor, run by PureTech at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: approximately 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.