Actively Recruiting
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
Led by Zumutor Biologics Inc. · Updated on 2026-04-02
100
Participants Needed
3
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older at the time of consent
- Patients with advanced or metastatic solid tumors of selected histologies including NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, prostate cancer, colorectal cancer, pancreatic adenocarcinoma, biliary tract cancer, high grade serous ovarian cancer, diffuse large B cell lymphoma, kidney cancer, or urothelial cancer
- Patients whose tumors have progressed or require new anticancer treatment
- Patients with measurable disease by RECIST 1.1 on CT, PET/CT, or MRI within 3 weeks before consent; non-measurable disease allowed in Part 1 with approval
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1, except RCC patients in Part 1 can have PS up to 2
- Adequate hematologic function: hemoglobin ≥9 g/dL, ANC ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L
- Adequate hepatic function: total bilirubin ≤1.5 times upper limit of normal (ULN), AST and ALT ≤3 times ULN (up to 5 times if liver metastases present)
- Adequate renal function: creatinine clearance ≥30 mL/min
- Women of childbearing potential and men with partners who are women of childbearing potential must agree to contraception from consent through 4 months after last dose
- Suitable venous access for drug administration and sampling
- Permission to access archival biopsy tissue; fresh biopsies encouraged in Part 1 and required in Part 2 unless contraindicated
- Patients with tumors having actionable mutations must have progressed on or be contraindicated for approved targeted therapies
You will not qualify if you...
- Patients not recovered to Grade 0/1 or baseline from prior treatment toxicities except alopecia and peripheral neuropathy
- Uncontrolled brain metastases; stable treated brain metastases allowed with low-dose prednisone
- Recent radiotherapy within 4 weeks without recovery to Grade ≤1 except alopecia
- Active infection requiring antibiotics at first dose
- Serious uncontrolled medical disorders or psychiatric illness limiting compliance
- Active second invasive malignancy except stable prostate cancer on watchful waiting, in situ cervical or breast carcinoma, or localized non-melanoma skin cancers
- Uncontrolled or significant cardiovascular disease (NYHA Class III or IV)
- QTc interval >470 msec without pacemaker
- Active autoimmune disease requiring systemic treatment; controlled endocrine or autoimmune conditions allowed
- Use of therapeutic immunosuppressive medication within 28 days prior to first dose
- Prior immune checkpoint inhibitor treatment discontinued due to immune-related adverse events without resolution to Grade 1 or need for steroids
- History of interstitial lung disease, pneumonitis, active pulmonary tuberculosis, or active lung infections
- Live vaccine received within 30 days prior to enrollment
- Known active hepatitis B or C infection
- HIV positive patients eligible only in Part 2 with specific criteria
- Known or suspected allergy to trial treatments or related products
- Prior allogeneic bone marrow or solid organ transplantation
- Contraindications to Toripalimab for patients in the combination cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jyotsna Fuloria, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here