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New treatment option for Non Small Cell Lung Cancer
Official title This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06451497
What this study is testing
What is ZM008?
ZM008 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients aged 18 years and older, at the time of signing the informed consent form.
- Part 1: Patients with histologically confirmed diagnosis of advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid...
- Patients with tumors with actionable mutations should have progressed to all approved targeted therapies or have them contraindicated.
- The patient has measurable disease with RECIST 1. 1 on computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging...
- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Patients with renal cell carcinoma (RCC) to be allocated to a...
You likely can't join if
- Patients should have recovered from toxicity related to previous anticancer treatments (including surgery and radiation) to Grade 0/1 or baseline...
- The patient has a history of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery...
- The patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation)...
- The patient had an active infection requiring parenteral or oral antibiotics at the time of the first dose. Patients receiving oral antibiotics can...
- The patient has evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or Medical Monitor, makes it unwise for...
- The patient has a psychiatric illness/social circumstance that would limit compliance with trial requirements and substantially increase the risk of...
See the full eligibility criteria
Who can join
- Adult patients aged 18 years and older, at the time of signing the informed consent form.
- Part 1: Patients with histologically confirmed diagnosis of advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven...
- Patients with tumors with actionable mutations should have progressed to all approved targeted therapies or have them contraindicated.
- The patient has measurable disease with RECIST 1. 1 on computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) scan. Imaging tests outside the screening period are valid if...
- The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Patients with renal cell carcinoma (RCC) to be allocated to a backfill cohort in Part 1 can have PS ≤2.
- The patient has adequate hematologic function as defined by:
- Hemoglobin ≥9 g/dL (whole or partial blood transfusions not allowed in the two previous weeks).
- Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factors like granulocyte colony-stimulating factor are not allowed in the two previous weeks).
- Platelet count ≥75 × 109/L (platelet transfusions are not allowed in the two previous weeks).
- The patient has adequate hepatic function as defined by:
- Total bilirubin ≤1.5 times upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, (if liver metastases are present, then ≤5.0 times ULN is allowed).
- The patient has adequate renal function as defined by: estimated creatinine clearance (CrCL) using the Cockcroft- Gault formula ≥30 mL/minute.
- Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must consent to adhere to contraceptive requirements as detailed in the protocol from the day of the signature of the informed consent...
- Suitable venous access for safe drug administration and the trial-required drug concentration and pharmacodynamic sampling.
- Permission to access archival biopsy located at the treating site or elsewhere. Note: Archival tissue does not need to be checked before Cycle 1 Day 1. The most modern archival biopsy is requested. If no archival tissue...
- Pretreatment fresh biopsy is highly encouraged in Part 1 dose escalation once BED has been achieved. In Part 2, fresh pre-treatment and on-treatment biopsies should be obtained unless biopsy is associated with...
What rules you out
- Patients should have recovered from toxicity related to previous anticancer treatments (including surgery and radiation) to Grade 0/1 or baseline (except alopecia and peripheral neuropathy). Patients with...
- The patient has a history of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain...
- The patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to Grade ≤1 or baseline from related side...
- The patient had an active infection requiring parenteral or oral antibiotics at the time of the first dose. Patients receiving oral antibiotics can be enrolled after discussion and approval of the trial Medical Monitor.
- The patient has evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or Medical Monitor, makes it unwise for the patient to participate in the trial or that might jeopardize...
- The patient has a psychiatric illness/social circumstance that would limit compliance with trial requirements and substantially increase the risk of AEs or has compromised ability to provide written informed consent.
- The patient has clinical evidence of an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma...
- The patient has uncontrolled or significant cardiovascular disease defined as New York Heart Association classification III or IV.
- The patient has baseline QTc (using the Fridericia correction calculation) \>470 msec in patients without pacemaker. Active autoimmune disease that is requiring systemic treatment (i.e., with use of disease modifying...
- Use of therapeutic immunosuppressive medication (eg, prednisone dose of ≥ 10 mg/day or equivalent, tumor necrosis factor inhibitors at any dose) within 28 days prior to the first planned dose of study treatment. This...
- For patients in the ZM008 monotherapy and combination arms: Patients who discontinued prior treatment with any immune checkpoint due to immune-related AEs, irrespective of grade, recovery, or need for continued steroid...
- History of interstitial lung disease/non-infectious pneumonitis, including immune-related pneumonitis of any Grade, radiation pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis on screening...
- The patient has live vaccines reception within 30 days of enrollment.
- Known active hepatitis B or C.
- Patients positive for human immunodeficiency virus (HIV) can be enrolled only in Part 2 of the trial, but HIV-positive patients must meet the following criteria: a. have CD4+ T cell (CD4+) counts ≥350 cells/μL. b. have...
- Has known or suspected allergy to trial treatment, excipients, or related products.
- Prior allogeneic bone marrow transplantation or solid organ transplantation.
- Toripalimab cohort only: Any contraindication present in the toripalimab prescribing information.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Austin, TX 78758, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Austin, TX 78758, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.