Description:
The primary objective of the study is:
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 naïve 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) and/or composite
response criteria
The secondary objectives of the study are:
Dose Escalation:
- To characterize the pharmacokinetics (PK) of REGN7075 alone and in combination with
cemiplimab
- 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
- To assess immunogenicity of REGN7075 and cemiplimab
Dose Expansion:
- 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
- To assess the safety and tolerability of REGN7075 in combination with cemiplimab
- To characterize the PK of REGN7075 alone and in combination with cemiplimab
- To assess immunogenicity to REGN7075 and cemiplimab
Title
- Brief Title: REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors
- Official Title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
R7075-ONC-2009
- NCT ID:
NCT04626635
Conditions
Interventions
Drug | Synonyms | Arms |
---|
REGN7075 | | Dose Escalation |
cemiplimab | REGN2810, Libtayo | Dose Escalation |
Purpose
The primary objective of the study is:
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 naïve 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) and/or composite
response criteria
The secondary objectives of the study are:
Dose Escalation:
- To characterize the pharmacokinetics (PK) of REGN7075 alone and in combination with
cemiplimab
- 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
- To assess immunogenicity of REGN7075 and cemiplimab
Dose Expansion:
- 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
- To assess the safety and tolerability of REGN7075 in combination with cemiplimab
- To characterize the PK of REGN7075 alone and in combination with cemiplimab
- To assess immunogenicity to REGN7075 and cemiplimab
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Variety of mixed advanced solid tumor types | |
Dose Expansion A | Experimental | Microsatellite-Stable Colorectal Cancer (MSS CRC) | |
Dose Expansion B | Experimental | Triple Negative Breast Cancer (TNBC) | |
Dose Expansion C | Experimental | Cutaneous Squamous Cell Carcinoma (CSCC) | |
Dose Expansion D | Experimental | Non-Small Cell Lung Cancer (NSCLC) | |
Eligibility Criteria
Key Inclusion Criteria:
1. ≥18 years of age (≥20 years of age for patients enrolled in Japan)
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Has histologically or cytologically confirmed cancer that meets criteria as defined in
the protocol
4. Is anti-PD-1/PD-L1 naïve, defined as never having previously been treated with a drug
that targets the PD-1 or PD-L1 pathway
5. Has at least 1 lesion that meets study criteria as defined in the protocol
6. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy)
from a tumor site that has not been previously irradiated
7. Has adequate organ and bone marrow function as defined in the protocol
8. 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-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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The incidence of dose-limiting toxicities (DLTs) during the DLT period |
Time Frame: | Up to 6 weeks |
Safety Issue: | |
Description: | Dose escalation |
Secondary Outcome Measures
Measure: | Drug concentrations of REGN7075 in serum |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Drug concentrations of cemiplimab |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | ORR |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation |
Measure: | Progression free survival (PFS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Disease control rate (DCR) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Complete response (CR) rate |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Overall survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Incidence of anti-drug antibodies (ADA) to REGN7075 |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | Incidence of ADA to cemiplimab |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose escalation and dose expansion |
Measure: | The incidence and severity of TEAEs |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose expansion |
Measure: | The incidence and severity of AESIs |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose expansion |
Measure: | The incidence and severity of SAEs |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose expansion |
Measure: | The incidence and severity of grade ≥3 laboratory abnormalities |
Time Frame: | Approximately 90 days from last dose; up to 5 years |
Safety Issue: | |
Description: | Dose expansion |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Variety of mixed advanced solid tumor types
- First in Human (FIH)
Last Updated
July 28, 2021