Oncology Clinical Trial
Official title:
A Phase 1 Study to Evaluate IMM27M Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced, Metastatic Solid Tumor
This is a single arm, open label, multi-center and fist in human dose escalation study, to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced and metastatic solid tumor.
Dose escalation (Ia) will recruit 16 disease progress after stand of care(SOC) , no tolerance of SOC solid tumor patients, including malignant melanoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer, ovarian cancer, endometrial cancer, triple negative breast cancer, small cell lung cancer, renal cell carcinoma, squamous cell cancer of head and neck, pancreatic cancer, etc. IMM27M will be dosed every three weeks (Q3W), the study will be conducted by adjusted 3+3 dose escalation study design, the fist dose is 0.1mg/kg based on the non-clinical study data and NOVEL assessment, the dose level will be 0.1, 0.3, 1.0, 2.0, 3.0 mg/kg, the first dose will recruit 1 patient to avoid patients under no efficacy dose, then the conventional 3+3 study design will start since second dose. Patients will be observed 3 weeks after the dose, this is also the DLT observation period, patients will be dosed until intolerability, progressed, death or informed consent withdraw, the total duration of treatment will be 48 weeks. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01439152 -
Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
| Active, not recruiting |
NCT06015009 -
Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers
|
N/A | |
| Active, not recruiting |
NCT03298100 -
Risk Scoring Model for Endometrial Cancer
|
||
| Recruiting |
NCT05055609 -
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT04324320 -
Psychological Distress in Outpatient Oncological Rehabilitation
|
||
| Completed |
NCT00588289 -
Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA
|
N/A | |
| Recruiting |
NCT06222801 -
The 1st Tumor CytokinoTherapy Database (TCTD-1)
|
||
| Recruiting |
NCT03831633 -
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
|
Phase 4 | |
| Completed |
NCT04914702 -
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
|
||
| Recruiting |
NCT05198570 -
Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
|
||
| Recruiting |
NCT05712174 -
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT03832062 -
Value of Analysing Under-utilised Leftover Tissue (VauLT)
|
||
| Completed |
NCT03988777 -
Magnetic Seed Localisation for Nonpalpable Breast Lesions
|
||
| Recruiting |
NCT06031233 -
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie
|
Phase 4 | |
| Enrolling by invitation |
NCT04019119 -
Digital Intervention for the Modification of Lifestyles (iGame)
|
N/A | |
| Not yet recruiting |
NCT05926362 -
Capillary-Venous Paired Data Collection
|
||
| Recruiting |
NCT05510856 -
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients
|
Phase 4 | |
| Recruiting |
NCT05686213 -
ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial
|
Phase 2 | |
| Completed |
NCT04180306 -
PEWS Implementation in an LMIC Setting
|
N/A |