AzTrials
AzTrials

Non Small Cell Lung CancerPhase 1NCT06451497

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

A Phase 1 study testing ZM008 in people with Non Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by Zumutor Biologics Inc. at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ZM008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesUnited States
Study dates
22 May 2024to Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • 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 clinical benefit or are intolerant to these therapies with the following selected tumor histologies: NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, prostate cancer, colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, high grade serous ovarian cancer, diffuse large B cell lymphoma, kidney cancer, or urothelial cancer. This selection corresponds to tumor histologies known to express higher LLT1 levels. Other tumor histologies can be enrolled only if approved by the sponsor after discussion with the investigator. Tumors should be progressing or deserving another anticancer treatment in the opinion of the investigator. Part 2: The same patient population as Part 1 although it will be enriched or modified based on the observed antitumor activity observed in Part 1. In case the patient population is modified to include patients with standard therapeutic alternatives, a substantial amendment will be issued.
  • 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 performed not more than 3 weeks before consent signature and otherwise fulfill protocol criteria. Patients with non-measurable disease may be allowed in Part 1 only with the explicit approval of the trial Medical Monitor.
  • 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:
Show all 17Show fewer
  • 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 to at least 4 months after the last dose of trial treatment.
  • 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 is available, the patient can still be enrolled in the escalation phase but not in Part 2.
  • 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 significant risk or declined by the patient and per discussion with the sponsor medical monitor (or designee).

Who cannot join

  • 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 endocrinopathies should have the replacement treatment in stable dosing.
  • 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 imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT) and considered controlled with <10 mg/day prednisone equivalent at the time of receiving the first dose of ZM008. For asymptomatic patients, screening brain imaging is not required.
  • 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 effects of such therapy (except for alopecia).
  • 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 compliance with the protocol.
  • 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.
Show all 18Show fewer
  • 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 skin cancers.
  • 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 agents, corticosteroids at >10 mg/day of equivalent prednisone, or immunosuppressive drugs at any dose). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Participants with adrenal insufficiency on oral steroid replacement are allowed to participate in the study. Participants with controlled type I diabetes mellitus on stable insulin regimen are also eligible for the study. Participants with rheumatoid arthritis or psoriasis may be eligible if they have not experienced a flare in 2 years and do not require systemic therapy within the past year. Participants with vitiligo are also eligible.
  • 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 does not include intranasal, intraocular, inhaled corticosteroids, topical and intra-articular joint injections, or physiologic replacement doses of systemic corticosteroids. Less than 10 mg prednisone per day or equivalent, short term, is allowed.
  • 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 therapy. Also, patients without formal contraindication due to previous irAE are not eligible if the AE has not resolved to Grade 1 or better and/or still requires steroids (>10 mg of prednisone equivalent per day) for ongoing management.
  • 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 chest CT scan. Participants with radiation therapy to the lung that is >30 Gy within 6 months of the first dose of treatment are excluded. Participants with active lung infections requiring treatment are also excluded.
  • 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 not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the trial. c. should be on established antiretroviral therapy for at least 4 weeks. d. have an HIV viral load of less than 400 copies/mL prior to enrollment. e. known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maloy Ghosh, PhD contact

+91 80 69121400

maloy.ghosh@zumutor.com

Jyotsna Fuloria, MD contact

5046062594

jyotsna.fuloria@fuloriaresearch.org

United States3 sites, 3 recruiting

  • NEXT Oncology

    Austin, TX 78758, Texas, 78758

    Andrae Vandross, MD, 210-580-9500

    Andrae Vandros, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Glenn Hanna, MD, 617-632-6799

    Glenn Hanna, MD

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Ildefonso Rivera, MD, 210-580-9500

    Ildefonso IR Rivera, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Dose Escalation Trial of ZM008, an Anti-LLT1 Antibody, as Single Agent Followed by Combination With Toripalimab in Patients With Advanced Solid Tumors

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.

Being tested
ZM008
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Biliary Tract Neoplasms, Prostatic Neoplasms, Carcinoma, Transitional Cell, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZM008Biological

    Also called Antibody

    Intravenous delivery

Study groups in NCT06451497
Study groupRoleWhat they receive
Single arm dosing with ZM008 and in combination with ToripalimabExperimentalDose escalation of ZM008 alone and in combination with Toripalimab.
Receives: Biological: ZM008

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nature and frequency of dose limiting toxicities per Common Toxicity Criteria for Adverse Events version 5

    Adverse Events to be assessed.

    Measured: This starts at the beginning of screening procedures and upto 90 days after completion of the last cycle of investigational product administration with each cycle of 21 days duration.

  2. Change in systolic and diastolic BP,

    Systolic \& Diastolic measurements will be in mmHg

    Measured: During screening (baseline), through the administration of investigational product (Day1 of each treatment cycle which is 21 days), end of treatment visit which is 30 days after completion of the last treatment cycle.

  3. Change in Heart Rate

    This will be measured in beats per minute.

    Measured: During screening (baseline), through the administration of investigational product, (Day1 of each treatment cycle of 21 days duration), end of treatment visit at 30 days after completion of last cycle of investigational product.]

  4. Changes in Temperature measurements.

    This will be measured in degrees Fahrenheit

    Measured: During screening (baseline), through the administration of investigational product, (Day1 of each treatment cycle of 21 days duration), end of treatment visit at 30 days after completion of last cycle of investigational product.]

  5. Change in pulse ox measurements on room air

    Measurement of peripheral oxygen saturation as a percentage

    Measured: This starts at the beginning of screening procedures and upto 90 days after completion of the last cycle of investigational product administration with each cycle of 21 days duration.

Secondary outcomes (9)

  1. Overall Response Rate (ORR) per RECIST 1.1

    This calculation is defined as the percentage of patients with partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 version 5 based on local investigator assessment.

    Measured: Assessed at study completion in upto 36 months.

  2. Immune Overall Response Rate (iORR) per iRECIST

    This calculation is defined as the percentage of patients with partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors i(RECIST).

    Measured: Assessed at study completion in upto 36 months.

  3. Progression Free Survival

    This is defined as the start of study treatment until disease progression per RECIST 1.1 or death from any cause for patients that have not started any other treatment for tumor reduction.

    Measured: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  4. Immune Progression Free Survival

    This is defined as the start of study treatment until disease progression per iRECIST or death from any cause for patients that have not started any other treatment for tumor reduction.

    Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  5. Disease Control Rate

    This is defined as the percentage of patients with Complete Response, Partial Response and Stable Disease per RECIST criteria 1.1

    Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  6. Immune Disease Control Rate

    This is defined as the percentage of patients with Complete Response, Partial Response and Stable Disease per iRECIST criteria

    Measured: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  7. Immunogenicity of ZM008

    Blood will be drawn for antibodies against ZM008

    Measured: Baseline, and before every cycle of investigational product administration (with each cycle being 21 days duration) and 30 days after last cycle completion.

  8. Maximum Plasma Concentration of the biological product ZM008

    Blood will be drawn for evaluating the maximum plasma concentration in micrograms/milliliter

    Measured: Baseline, on Cycle 1 Day1 (before and end of ZM008 infusion, 2 hour, 6 hour, 10 hour and 24 hour after infusion), day 2, day 8 & day15. Blood tests will be repeated for Cycle 2. Cycle 3 &4 onwards only Day 1 blood will be drawn. Cycle duration is 21 days

  9. Area Under the Plasma Concentration Versus Time Curve (AUC) of the biological product ZM008

    Blood will be drawn at periodic intervals and the measure expressed as microgram/milliliter versus time in hours

    Measured: Baseline, on Cycle 1 Day1 (before and end of ZM008 infusion, 2 hour, 6 hour, 10 hour and 24 hour after infusion), day 2, day 8 & day15. Blood tests will be repeated for Cycle 2. Cycle 3 &4 onwards only Day 1 blood will be drawn. Cycle duration is 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start22 May 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06451497
Sponsor's protocol ID
ZM008-001
Status last verified
Mar 2026
First submitted
14 May 2024
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZM008 in people with Non Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by Zumutor Biologics Inc. at 3 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 17 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maloy Ghosh, PhD (+91 80 69121400, maloy.ghosh@zumutor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nature and frequency of dose limiting toxicities per Common Toxicity Criteria for Adverse Events version 5 (time frame: This starts at the beginning of screening procedures and upto 90 days after completion of the last cycle of investigational product administration with each cycle of 21 days duration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06451497.

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 2 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in