Trial Title:
A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors
NCT ID:
NCT05746897
Condition:
Ovarian Cancer
Melanoma
Triple Negative Breast Cancer
Colorectal Cancer
Conditions: Official terms:
Triple Negative Breast Neoplasms
Pembrolizumab
Conditions: Keywords:
solid tumors，NM1F，Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NM1F Injection
Description:
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the
tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy
and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally
advanced, or metastatic solid tumors.
The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose
escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject
in the two parts, the study will include a screening period (up to 28 days), a treatment
period (until treatment discontinuation), and a follow-up period.
Arm group label:
NM1F Injection/pembrolizumab Injection
Intervention type:
Drug
Intervention name:
Pembrolizumab injection
Description:
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the
tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy
and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally
advanced, or metastatic solid tumors.
The study consists of two parts: NM1F monotherapy dose escalation (Phase 1a), NM1F dose
escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject
in the two parts, the study will include a screening period (up to 28 days), a treatment
period (until treatment discontinuation), and a follow-up period.
Arm group label:
NM1F Injection/pembrolizumab Injection
Summary:
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
Detailed description:
This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the
tolerability, safety, PK/PD, and preliminary anti-tumor activity of NM1F as monotherapy
and in combination with pembrolizumab (Keytruda®) in subjects with unresectable locally
advanced, or metastatic solid tumors.
The study consists of two parts : NM1F monotherapy dose escalation (Phase 1a), NM1F dose
escalation in combination with a fixed dose of pembrolizumab (Phase 1b). For each subject
in the two parts, the study will include a screening period (up to 28 days), a treatment
period (1 year and 2 years for Phase 1a and 1b, respectively, or until treatment
discontinuation), and a follow-up period .
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female subjects age ≥ 18 years at the time of informed consent.
2. Subjects with histologically or cytologically diagnosed unresectable locally
advanced, or metastatic solid tumors, mainly but not limited to CRC, TNBC, melanoma,
OC, and who have progressed despite all standard therapy or are intolerant of all
standard therapy, or for whom no effective standard therapy exists
3. Subjects must have at least 1 evaluable lesion as defined by response evaluation
criteria in solid tumors (RECIST) v1.1.
4. ECOG PS of 0~2.
5. Life expectancy ≥ 3 months.
6. Subjects have sufficient baseline organ function and laboratory data.
7. Woman of childbearing potential must have a negative serum pregnancy test within 7
days prior to treatment.
8. Female subjects of childbearing potential or male subjects with a partner of
childbearing potential must agree to use effective contraception at the time of
informed consent and continuing through the study until 6 months after the last dose
of NM1F and / or pembrolizumab.
- Exclusion Criteria:
Cancer Related
1. Subject with known active central nervous system (CNS) primary tumor or metastases.
2. History of intercurrent severe chronic or active infections.
3. Has a history of active autoimmune diseases , or is receiving chronic systemic
steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any
other form of immunosuppressive therapy within 14 days prior the first dose of study
drug.
4. Has a history of symptomatic interstitial lung disease or inflammatory pneumonitis.
5. Has a history of impaired cardiac function or clinically significant cardiovascular
diseases.
6. Prior allogenic or autologous bone marrow transplantation or other solid organ
transplantation.
7. Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years (Note: Exceptions are subjects with basal cell
carcinoma of the skin, squamous cell carcinoma of the skin, and localized prostate
cancer who have undergone potentially curative therapy. These subjects are not
excluded).
8. Evidence of clinically significant immunosuppression such as the following:
1. Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
(SCID)
2. Concurrent opportunistic infection
9. Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring
recurrent drainage procedures (monthly or more frequently).
10. Has received prior anticancer treatment with the following therapies (specified time
periods are from last dose of prior treatment to first dose of NM1F):
1. Any therapy directed against PVRIG (COM701 or other anti-PVRIG mAb) or other
CD226 axis receptor (TIGIT or CD96) at any time.
2. Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within
28 days or 5 half-lives, whichever is shorter, prior to the first dose of study
treatment.
3. Prior radiotherapy ≤ 4 weeks prior to the first dose of study treatment, with
the exception of a single fraction of radiotherapy for the purposes of
palliation, which is permitted.
4. Investigational therapy: if the subject has participated in a clinical study
and has received an investigational product within 4 weeks prior to the first
dose of study treatment.
11. Has received systematic immunomodulatory drugs within 14 days before the first dose
of study drug, such as thymosin, IL-2, IFN.
12. Has received a live vaccine within 4 weeks prior to the first dose of study drug.
13. Has a recent major surgery within 4 weeks prior to the first dose of study drug or
is expected to undergo major surgery during the study.
14. Toxicities of prior therapies have not been resolved to ≤ Grade 1 or baseline as per
NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation.
15. Subjects who have experienced Grade ≥ 3 irAEs from prior immunotherapies or who
discontinue immunotherapy due to immune-related toxicities.
16. Has a known psychiatric or substance abuse disorder that would interfere with the
subject's ability to cooperate with the requirements of the study.
17. Pregnancy or lactation. Women who are willing to discontinue breastfeeding prior to
administration of study drug and do not intend to resume breastfeeding may be
enrolled.
18. Has known hypersensitivity to either the drug substances or inactive ingredients in
the drug product.
19. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the best
interest of the subject to participate, in the opinion of the investigator.
20. Subjects who are unwilling or unable to comply with study procedures and study
restrictions, or in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
21. Subjects who have contraindication for use of PD-1/PD-L1 antibody (only for Phase
1b).
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NEXT Oncology, Dallas
Address:
City:
Dallas
Zip:
75039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Torres
Phone:
737-610-5205
Email:
etorres@nextoncology.com
Facility:
Name:
Next Oncology, Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Phone:
703-783-4505
Email:
bpatterson@nextoncology.com
Start date:
April 13, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Hefei TG ImmunoPharma Co., Ltd.
Agency class:
Other
Source:
Hefei TG ImmunoPharma Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746897
