A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors.
Primary Objective(s):
Dose Escalation: To assess the safety and tolerability of a REGN7075 monotherapy lead-in and REGN7075 in combination with cemiplimab in patients with advanced solid tumors that are naive to anti-PD-1/PD-L1 therapies.
Dose Expansion: To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts, as measured by objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Eisenhauer, 2009) and/or composite response criteria (depending on the patients baseline evaluation criteria).
Secondary Objective(s):
Dose Escalation:
(1) To characterize the pharmacokinetics (PK) of REGN7075 alone and in combination with cemiplimab.
(2) To assess the preliminary efficacy of REGN7075 in combination with cemiplimab, as measured by ORR, overall survival (OS), progression free survival (PFS), duration of response (DOR), complete response (CR) rate, and disease control rate (DCR) per RECIST 1.1 and/or composite response criteria (depending on the patient s baseline evaluation criteria).
(3) To assess immunogenicity of REGN7075 and cemiplimab.
Dose Expansion:
(1) To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts of patients as measured by OS, PFS, DOR, CR rate, and DCR per RECIST 1.1 and/or composite response criteria (depending on the patient s baseline evaluation criteria).
(2) To assess the safety and tolerability of REGN7075 in combination with cemiplimab.
(3) To characterize the PK of REGN7075 alone and in combination with cemiplimab.
(4) To assess immunogenicity to REGN7075 and cemiplimab.
Cemiplimab (REGN2810)
Chemotherapy single agent systemic
- Rutgers Cancer Institute of New Jersey
Key Inclusion Criteria
1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Has histologically or cytologically confirmed cancer that meets criteria as defined in
the protocol
3. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed cell
death ligand-1 (PD-L1) naïve, defined as never having previously been treated with a
drug that targets the PD-1
4. Has at least 1 lesion that meets study criteria as defined in the protocol
5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy)
from a tumor site that has not been previously irradiated
6. Has adequate organ and bone marrow function as defined in the protocol
7. In the judgement of the investigator, has a life expectancy of at least 3 months
Key Exclusion Criteria
1. Is currently participating in another study of a therapeutic agent
2. Has participated in any study of an investigational agent or an investigational device
within 4 weeks of the first administration of study drug as defined in the protocol
3. Has received treatment with an approved systemic therapy within 4 weeks of the first
administration of study drug or has not yet recovered (ie, grade 1 or baseline) from
any acute toxicities
4. Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as
defined in the protocol
5. Has received radiation therapy or major surgery within 14 days of the first
administration of study drug or has not recovered (ie, grade 1 or baseline) from
adverse events
6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4
weeks of first administration of study drug.
7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as
defined in the protocol
8. Has second malignancy that is progressing or requires active treatment as defined in
the protocol
9. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg
prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first
dose of study drug as defined in the protocol
10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or
any other condition that required treatment with systemic immunosuppressive treatments
as defined in the protocol
11. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease,
or spinal cord compression
12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or
uncontrolled seizures within 1 year prior to the first dose of study drug
13. Has any ongoing inflammatory skin disease as defined in the protocol
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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