REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors
a study on Solid Tumor Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
Summary
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
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
- To assess the effect of REGN7075 on patient-reported outcomes, including health related quality of life (HRQoL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC QLQ-CR29 (among CRC patients only), EORTC-QLQ-BR23 (breast cancer patients only), EORTC QLQ-LC13 (among NSCLC patients only) and EORTC QLQ-HN35 (among HNSCC patients only) and EQ-5D-5L
Official Title
A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Keywords
Advanced Solid Tumors, Variety of mixed advanced solid tumor types, First in Human (FIH), Neoplasms, Cemiplimab, REGN7075
Eligibility
You can join if…
Open to people ages 18 years and up
- ≥18 years of age (≥20 years of age for patients enrolled in Japan)
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
- 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
- Has at least 1 lesion that meets study criteria as defined in the protocol
- Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
- Has adequate organ and bone marrow function as defined in the protocol
- In the judgement of the investigator, has a life expectancy of at least 3 months
You CAN'T join if...
- Is currently participating in another study of a therapeutic agent
- 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
- 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
- Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
- 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
- Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
- Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
- Has second malignancy that is progressing or requires active treatment as defined in the protocol
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
Locations
- The Regents of the UCSF (UCSF)
accepting new patients
San Francisco California 840011 United States - START - South Texas Accelerated Research Therapeutics, LLC
accepting new patients
San Antonio Texas 78229 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Regeneron Pharmaceuticals
- ID
- NCT04626635
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 434 study participants
- Last Updated
Frequently Asked Questions
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