Actively Recruiting
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
Led by Hefei TG ImmunoPharma Co., Ltd. · Updated on 2024-01-26
38
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NM1F, an investigational drug, alone and combined with pembrolizumab (Keytruda®) in people with locally advanced or metastatic solid tumors who have limited treatment options. This Phase 1 study aims to assess the safety, tolerability, how the body processes NM1F, and early signs of anti-tumor activity. The trial is open-label and involves multiple centers. The study has two parts: first, NM1F is given alone in a dose escalation phase (Phase 1a), then NM1F is given with a fixed dose of pembrolizumab in a second dose escalation phase (Phase 1b). Each participant undergoes a screening period up to 28 days, followed by a treatment period lasting up to one year for Phase 1a or up to two years for Phase 1b, or until treatment stops. After treatment, participants enter a follow-up period for further monitoring. Participants will have medical evaluations including scans to measure tumor response, safety assessments, and blood tests to study drug levels and immune response. The main outcomes include assessing dose-limiting toxicities during the first 21 days, frequency and severity of side effects, and determining the best dose over about three years. Researchers will also measure tumor response rates, duration of response, disease control, progression-free survival, and overall survival. The total study duration can be up to several years including follow-up.
CONDITIONS
Brief 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 18 years or older at the time of informed consent
- Diagnosed with unresectable locally advanced or metastatic solid tumors, including colorectal cancer, triple negative breast cancer, melanoma, or ovarian cancer
- Have at least one measurable lesion as defined by RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Life expectancy of at least 3 months
- Adequate baseline organ function and laboratory results
- Negative pregnancy test within 7 days prior to treatment for women of childbearing potential
- Agree to use effective contraception during the study and for 6 months after last dose if of childbearing potential or with a partner who is
You will not qualify if you...
- Known active central nervous system (CNS) primary tumor or metastases
- History of severe chronic or active infections
- Active autoimmune diseases or receiving immunosuppressive therapy exceeding 10 mg prednisone daily within 14 days before first dose
- Symptomatic interstitial lung disease or inflammatory pneumonitis
- Impaired cardiac function or significant cardiovascular diseases
- Prior bone marrow or solid organ transplantation
- Additional malignancy requiring treatment within past 3 years except certain skin cancers and localized prostate cancer
- Clinically significant immunosuppression such as primary immunodeficiency or opportunistic infection
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Prior treatment targeting PVRIG or CD226 axis receptors
- Recent chemotherapy, targeted therapy, immunotherapy, or radiotherapy within specified timeframes before first dose
- Participation in another investigational study within 4 weeks prior to first dose
- Recent use of immunomodulatory drugs or live vaccines within specified timeframes
- Recent major surgery within 4 weeks prior to first dose
- Unresolved toxicities from prior therapies above Grade 1 except alopecia or skin pigmentation
- Prior severe immune-related adverse events from immunotherapies
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy or lactation
- Known hypersensitivity to study drugs or ingredients
- Conditions interfering with study or judged unsuitable by investigator
- Inability or unwillingness to comply with study procedures
- Contraindication for PD-1/PD-L1 antibody use (Phase 1b only)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 1 to 2 years or until treatment discontinuation
Participants receive NM1F as monotherapy or in combination with pembrolizumab to evaluate safety, tolerability, and anti-tumor activity.
Visit schedule depends on dosing and assessments during treatment period
Duration - At least 30 days after last dose
Participants are monitored for safety and adverse events after treatment ends.
Approximately 1 to 2 follow-up visits
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
H
Hang Zhou, Bachelor
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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