Actively Recruiting
A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
Led by Hefei TG ImmunoPharma Co., Ltd. · Updated on 2024-01-26
38
Participants Needed
2
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination with Pembrolizumab in Subjects with Locally Advanced/Metastatic Solid Tumors
CONDITIONS
Official Title
A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects age 63 18 years at the time of informed consent.
- Histologically or cytologically diagnosed unresectable locally advanced or metastatic solid tumors, mainly colorectal cancer, triple negative breast cancer, melanoma, ovarian cancer.
- Tumors must have progressed despite all standard therapy, be intolerant to standard therapy, or have no effective standard therapy.
- At least one evaluable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
- Sufficient baseline organ function and laboratory data.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before treatment.
- Female subjects of childbearing potential or male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of NM1F and/or pembrolizumab.
You will not qualify if you...
- Known active central nervous system primary tumor or metastases.
- History of severe chronic or active infections.
- History of active autoimmune diseases or receiving chronic systemic steroid therapy exceeding 10 mg daily prednisone equivalent or other immunosuppressive therapy within 14 days before the first dose.
- History of symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of impaired cardiac function or significant cardiovascular diseases.
- Prior allogenic or autologous bone marrow transplantation or solid organ transplantation.
- Additional malignancy progressing or requiring active treatment within the past 3 years, except specific skin cancers and localized prostate cancer treated curatively.
- Clinically significant immunosuppression such as primary immunodeficiency or opportunistic infection.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
- Prior treatment with therapies targeting PVRIG or CD226 axis receptors.
- Chemotherapy, targeted therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives before first dose.
- Radiotherapy within 4 weeks before first dose, except single fraction for palliation.
- Participation in investigational therapy within 4 weeks before first dose.
- Use of systemic immunomodulatory drugs within 14 days before first dose.
- Receipt of live vaccine within 4 weeks before first dose.
- Recent major surgery within 4 weeks before first dose or planned major surgery during study.
- Unresolved toxicities from prior therapies greater than Grade 1 except alopecia and skin hyperpigmentation.
- Previous Grade 3 or higher immune-related adverse events from immunotherapy or discontinuation due to immune toxicities.
- Psychiatric or substance abuse disorder interfering with study cooperation.
- Pregnancy or lactation; breastfeeding must be discontinued prior to treatment.
- Known hypersensitivity to study drugs or ingredients.
- Any condition, therapy, or lab abnormality that might affect study results or participation.
- Inability or unwillingness to comply with study procedures or restrictions.
- Contraindication for PD-1/PD-L1 antibody use (Phase 1b only).
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NEXT Oncology, Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
2
Next Oncology, Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
X
Xiaohu Zheng, Doctorate
CONTACT
H
Hang Zhou, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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