Actively Recruiting
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
Led by Zumutor Biologics Inc. · Updated on 2026-04-02
100
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ZM008, an anti-LLT1 antibody, alone and combined with Toripalimab, for patients with advanced solid tumors who have no standard treatment options left or cannot tolerate them. This phase 1 dose escalation trial focuses on assessing safety and dosage levels in patients with various cancers including lung, breast, head and neck, prostate, colorectal, pancreatic, ovarian, lymphoma, kidney, and urothelial cancers. The study involves giving ZM008 intravenously by itself initially, followed by combination treatment with Toripalimab. The treatment cycles are 21 days long, and patients will receive escalating doses to find the appropriate dose level. The trial has a single experimental arm with dose escalation of ZM008 alone and then combined with Toripalimab. Participants will be monitored through screening and treatment cycles for up to 90 days after their last dose, with assessments including vital signs such as blood pressure, heart rate, temperature, and oxygen levels. Blood samples will be collected to study drug levels and immune response. Researchers will also track tumor response and progression for up to 36 months. Safety and side effects will be carefully observed throughout the study period.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years and older at the time of signing informed consent
- Histologically confirmed advanced or metastatic solid tumors with no standard therapeutic option or intolerance to standard therapies, including specific tumor types like 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
- Patients with tumors having actionable mutations must have progressed on all approved targeted therapies or have them contraindicated
- Measurable disease by RECIST 1.1 on CT, PET/CT, or MRI within 3 weeks before consent; non-measurable disease allowed in Part 1 only with approval
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (up to 2 for renal cell carcinoma backfill cohort)
- Adequate hematologic function (hemoglobin ≥9 g/dL, ANC ≥1.0 x 10⁹/L, platelets ≥75 x 10⁹/L) without recent transfusions or growth factors
- Adequate hepatic function (total bilirubin ≤1.5x ULN, AST and ALT ≤3x ULN or ≤5x ULN with liver metastases)
- Adequate renal function (creatinine clearance ≥30 mL/min)
- Women of childbearing potential and men with partners who are WOCBP must agree to contraceptive requirements
- Suitable venous access for drug administration and sampling
- Permission to access archival biopsy tissue; fresh biopsy encouraged in Part 1 and required in Part 2 unless declined or risky
You will not qualify if you...
- Unresolved toxicity from prior anticancer treatments greater than Grade 1 except alopecia and peripheral neuropathy
- Uncontrolled brain metastasis; stable treated brain metastases allowed with low-dose prednisone
- Recent extensive radiotherapy within 4 weeks or 2 weeks for limited field and not recovered to Grade 1 or baseline
- Active infection requiring antibiotics at first dose
- Serious uncontrolled medical disorders or psychiatric illness limiting trial compliance
- Active second invasive malignancy except certain stable or localized cancers
- Uncontrolled or severe cardiovascular disease (NYHA III or IV)
- Baseline QTc >470 msec in patients without pacemaker
- Active autoimmune disease requiring systemic treatment above specified doses
- Recent use of therapeutic immunosuppressive medication within 28 days prior to first dose
- Prior immune checkpoint inhibitor discontinuation due to immune-related adverse events not resolved to Grade 1 or requiring steroids >10 mg prednisone equivalent
- History of interstitial lung disease, pneumonitis, active pulmonary infections, or recent high-dose lung radiation
- Receipt of live vaccines within 30 days of enrollment
- Known active hepatitis B or C
- HIV positive patients only eligible in Part 2 with specified controlled criteria
- Known or suspected allergy to trial treatment or related products
- Prior allogeneic bone marrow or solid organ transplantation
- Contraindications as per toripalimab prescribing information for combination cohort only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive intravenous ZM008 alone followed by combination treatment with Toripalimab in cycles. Each treatment cycle lasts 21 days during which participants are monitored for safety and response.
Visits on Day 1 of each 21-day cycle with additional blood tests on specified days in early cycles
Duration - Up to 90 days after last treatment cycle
Participants are monitored for safety and treatment effects for up to 90 days after completing the last treatment cycle.
1 end of treatment visit approximately 30 days after last cycle and additional safety monitoring visits
Trial Site Locations
Total: 3 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
NEXT Oncology
Austin, TX 78758, Texas, United States, 78758
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Maloy Ghosh, PhD
J
Jyotsna Fuloria, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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