Phase 1 ZM008 and Toripalimab for Advanced Solid Tumors
This study is testing a new treatment called ZM008, an antibody, first by itself and then in combination with another drug called Toripalimab. It's for people with advanced solid tumors, such as non-small cell lung cancer, head and neck squamous cell carcinoma, pancreatic adenocarcinoma, biliary tract cancer, or prostate cancer, who have already tried standard treatments or can't tolerate them. The main goal is to see how safe the treatment is and what side effects it might cause, especially looking at dose-limiting toxicities (serious side effects that might require reducing the dose). Researchers will also monitor your blood pressure and heart rate. You can join if you are 18 or older and have one of the specified advanced solid tumors.
- Study design
- This is a Phase 1 study, meaning it's an early-stage trial to test safety and dosage. It plans to enroll 100 adult participants.
- What's involved
- You would receive ZM008 intravenously (through a vein). Treatment cycles are 21 days long. Your blood pressure and heart rate will be checked during screening, on Day 1 of each treatment cycle, and at a follow-up visit 30 days after your last treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety up to 90 days after completing your last treatment cycle, and for blood pressure and heart rate changes 30 days after your last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Maloy Ghosh, PhD · STUDY_CHAIR · Zumutor Biologics Inc.
- Jyotsna Fuloria · STUDY_DIRECTOR · Fuloria Clinical Research Solutions LLC
Who to contact
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What this trial measures
- Nature and frequency of dose limiting toxicities per Common Toxicity Criteria for Adverse Events version 5This 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.
Adverse Events to be assessed.
- Change in systolic and diastolic BP,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.
Systolic \& Diastolic measurements will be in mmHg
- Change in Heart RateDuring 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.]
This will be measured in beats per minute.
- Changes in Temperature measurements.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.]
This will be measured in degrees Fahrenheit
- Change in pulse ox measurements on room airThis 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.
Measurement of peripheral oxygen saturation as a percentage