Advanced Solid TumorsPhase 1/2COMBINE-EGFR-1NCT04626635
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
A Phase 1/2 study testing REGN7075, Cemiplimab and Platinum-based doublet chemotherapy in people with Advanced Solid Tumors, run by Regeneron Pharmaceuticals at 54 sites in 7 countries.
Trial summary
This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- REGN7075, Cemiplimab and Platinum-based doublet chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 54 sitesin 7 countries
- Study dates
- 21 Dec 2020to 5 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- 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
- Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression
- Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
- Has any ongoing inflammatory skin disease as defined in the protocol
- NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Trial locations and contacts
54 sites in 7 countries.
54 sites in 7 countries
United States20 sites
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic
Aurora, Colorado, 80045
University of Illinois Cancer Center
Chicago, Illinois, 60612
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
The Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
University of Florida Health
Gainesville, Florida, 32608
START Midwest - Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Valkyrie Clinical Trials
Los Angeles, California, 90067
University of California Los Angeles (UCLA) Medical Center
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute - 25th Ave
Nashville, Tennessee, 37203
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
South Texas Oncology And Hematology
San Antonio, Texas, 78229
The Regents of the University of California, San Francisco
San Francisco, California, 94118
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
France12 sites
Institut Bergonie
Bordeaux, New Aquitaine, 33076
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, 21034
Centre Hospitalier Universitaire (CHU) de Lille
Lille, Hauts-de-France, 59000
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone, 69008
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, 06189
Hospital Paris Saint-Joseph
Paris, 75014
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, 69310
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, New Aquitaine, 86021
Begin Army Instruction Hospital
Saint-Mandé, Île-de-France Region, 94240
Institut Claudius Regaud, IUCT-Oncopole
Toulouse, Haute-Garonne, 31059
Gustave Roussy
Villejuif, Île-de-France Region, 94800
Spain8 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Genesis Care Hospital San Francisco de Asis
Madrid, 28002
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital Clinico Universitario - University of Valencia
Valencia, 28040
Israel6 sites
Soroka University Medical Center
Beersheba, 84101
Rambam Health Care Campus
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center
Jerusalem, 91220
Sheba Medical Center
Ramat Gan, Central District, 5265601
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Turkey (Türkiye)4 sites
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06200
Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
Istanbul, 81450
Ciftlikkoy Campus Yenisehir Mersin
Mersin, 33343
Baskent Universitesi
Yüreğir, Adana, 01120
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, 1066 CX
Erasmus MC
Rotterdam, 3015 GD
Poland2 sites
Medpolonia Sp. z o.o.
Poznan, Wielkopolska, 60-693
Dom Lekarski SA
Szczecin, Zach, 70-784
About this study
Official title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.
Read more
The study is also looking at:
- Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy
- How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy
- How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
- To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
- Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)
- Conditions
- Advanced Solid Tumors
- Being tested
- REGN7075, Cemiplimab, Platinum-based doublet chemotherapy, Bevacizumab, Trifluridine-tipiracil
- Keywords
- Variety of mixed advanced solid tumor types, First in Human (FIH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7075Drug
Also called marlotamig
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
CemiplimabDrug
Also called REGN2810, Libtayo
Administered concomitantly Q3W by IV infusion or SC injection
Platinum-based doublet chemotherapyDrug
Administered IV Q3W
BevacizumabDrug
Administered per protocol
Trifluridine-tipiracilDrug
Administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Variety of mixed advanced solid tumor types Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion A | Experimental | Triple Negative Breast Cancer (TNBC) Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion B | Experimental | Cutaneous Squamous Cell Carcinoma (CSCC) Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion C | Experimental | Non-Small Cell Lung Cancer (NSCLC) Receives: Drug: REGN7075; Drug: Cemiplimab; Drug: Platinum-based doublet chemotherapy |
| Dose Expansion D | Experimental | Head and Neck Squamous Cell Carcinoma (HNSCC) Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion E | Experimental | Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion F | Experimental | MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases) Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion G | Experimental | Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI) Receives: Drug: REGN7075; Drug: Cemiplimab; Drug: Platinum-based doublet chemotherapy |
| Dose Expansion H | Experimental | EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy Receives: Drug: REGN7075; Drug: Cemiplimab |
| Dose Expansion I | Experimental | Third-line (3L) MSS-CRC with Active Liver Metastases Receives: Drug: REGN7075; Drug: Cemiplimab; Drug: Bevacizumab; Drug: Trifluridine-tipiracil |
| Dose Expansion J | Experimental | 3L MSS-CRC without Active Liver Metastases Receives: Drug: REGN7075; Drug: Cemiplimab; Drug: Bevacizumab; Drug: Trifluridine-tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period
Dose escalation
Measured: Up to 6 weeks
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Dose escalation
Measured: Approximately 90 days from last dose; up to 5 years
Incidence and severity of Adverse Events of Special Interest (AESIs)
Dose escalation
Measured: Approximately 90 days from last dose; up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Dose escalation
Measured: Approximately 90 days from last dose; up to 5 years
Incidence and severity of grade ≥3 laboratory abnormalities
Dose escalation
Measured: Approximately 90 days from last dose; up to 5 years
Objective Response Rate (ORR)
Dose expansion
Measured: Up to 5 years
Secondary outcomes (39)
Concentrations of marlotamig in serum
Dose escalation and dose expansion
Measured: Up to 5 years
ORR
Dose escalation
Measured: Up to 5 years
Progression Free Survival (PFS)
Dose escalation and dose expansion
Measured: Up to 5 years
Duration of Response (DOR)
Dose escalation and dose expansion
Measured: Up to 5 years
Disease Control Rate (DCR)
Dose escalation and dose expansion
Measured: Up to 5 years
Complete Response (CR) rate
Dose escalation and dose expansion
Measured: Up to 5 years
Overall survival (OS)
Dose escalation and dose expansion
Measured: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to marlotamig
Dose escalation and dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to marlotamig
Dose escalation and dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
Incidence of ADA to cemiplimab
Dose escalation and dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to cemiplimab
Dose escalation and dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
The incidence and severity of TEAEs
Dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
The incidence and severity of AESIs
Dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
The incidence and severity of SAEs
Dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
The incidence and severity of grade ≥3 laboratory abnormalities
Dose expansion
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain.
The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses.
The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). . Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain.
The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses.
The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain.
The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses.
The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-C30
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-CR29 in CRC patients
The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients
The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients
The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain.
The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients
The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses.
The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
Measured: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EQ-5D-5L
The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Approximately 90 days from last dose; up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start21 Dec 2020
- Primary completion13 Nov 2026 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626635
- Sponsor's protocol ID
- R7075-ONC-2009
- Other IDs
- 2022-501234-37-00
- Acronym
- COMBINE-EGFR-1
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04626635
- Acronym / sponsor ID
- COMBINE-EGFR-1 / R7075-ONC-2009
- Conditions
- Advanced Solid Tumors
- Keywords
- Variety of mixed advanced solid tumor types, First in Human (FIH)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.
The study is also looking at:
- Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy
- How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy
- How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
- To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
- Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: REGN7075, Drug: CemiplimabVariety of mixed advanced solid tumor types |
| Dose Expansion A | Experimental | Drug: REGN7075, Drug: CemiplimabTriple Negative Breast Cancer (TNBC) |
| Dose Expansion B | Experimental | Drug: REGN7075, Drug: CemiplimabCutaneous Squamous Cell Carcinoma (CSCC) |
| Dose Expansion C | Experimental | Drug: REGN7075, Drug: Cemiplimab, Drug: Platinum-based doublet chemotherapyNon-Small Cell Lung Cancer (NSCLC) |
| Dose Expansion D | Experimental | Drug: REGN7075, Drug: CemiplimabHead and Neck Squamous Cell Carcinoma (HNSCC) |
| Dose Expansion E | Experimental | Drug: REGN7075, Drug: CemiplimabMicrosatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases |
| Dose Expansion F | Experimental | Drug: REGN7075, Drug: CemiplimabMSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases) |
| Dose Expansion G | Experimental | Drug: REGN7075, Drug: Cemiplimab, Drug: Platinum-based doublet chemotherapyEpidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI) |
| Dose Expansion H | Experimental | Drug: REGN7075, Drug: CemiplimabEGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy |
| Dose Expansion I | Experimental | Drug: REGN7075, Drug: Cemiplimab, Drug: Bevacizumab, Drug: Trifluridine-tipiracilThird-line (3L) MSS-CRC with Active Liver Metastases |
| Dose Expansion J | Experimental | Drug: REGN7075, Drug: Cemiplimab, Drug: Bevacizumab, Drug: Trifluridine-tipiracil3L MSS-CRC without Active Liver Metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN7075Also: marlotamigIntravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W) | Drug | Dose Escalation, Dose Expansion A, Dose Expansion B, Dose Expansion C, Dose Expansion D, Dose Expansion E, Dose Expansion F, Dose Expansion G, Dose Expansion H, Dose Expansion I, Dose Expansion J |
| CemiplimabAlso: REGN2810, LibtayoAdministered concomitantly Q3W by IV infusion or SC injection | Drug | Dose Escalation, Dose Expansion A, Dose Expansion B, Dose Expansion C, Dose Expansion D, Dose Expansion E, Dose Expansion F, Dose Expansion G, Dose Expansion H, Dose Expansion I, Dose Expansion J |
| Platinum-based doublet chemotherapyAdministered IV Q3W | Drug | Dose Expansion C, Dose Expansion G |
| BevacizumabAdministered per protocol | Drug | Dose Expansion I, Dose Expansion J |
| Trifluridine-tipiracilAdministered per protocol | Drug | Dose Expansion I, Dose Expansion J |
Primary outcome
The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period
Time frame: Up to 6 weeks
Dose escalation
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of Adverse Events of Special Interest (AESIs)
Time frame: Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of Serious Adverse Events (SAEs)
Time frame: Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities
Time frame: Approximately 90 days from last dose; up to 5 years
Dose escalation
Objective Response Rate (ORR)
Time frame: Up to 5 years
Dose expansion
39 secondary outcomes
Concentrations of marlotamig in serum
Time frame: Up to 5 years
ORR
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Disease Control Rate (DCR)
Time frame: Up to 5 years
Complete Response (CR) rate
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to marlotamig
Time frame: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to marlotamig
Time frame: Approximately 90 days from last dose; up to 5 years
Incidence of ADA to cemiplimab
Time frame: Approximately 90 days from last dose; up to 5 years
Magnitude of ADA to cemiplimab
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of TEAEs
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of AESIs
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of SAEs
Time frame: Approximately 90 days from last dose; up to 5 years
The incidence and severity of grade ≥3 laboratory abnormalities
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported Quality of Life (QoL) per EQ-5D-5L
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-C30
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-CR29 in CRC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported symptoms per EQ-5D-5L
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-C30
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-CR29 in CRC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reported functioning per EQ-5D-5L
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-C30
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-CR29 in CRC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients
Time frame: Approximately 90 days from last dose; up to 5 years
Patient reporting general health status per EQ-5D-5L
Time frame: Approximately 90 days from last dose; up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
54 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN7075, Cemiplimab and Platinum-based doublet chemotherapy in people with Advanced Solid Tumors, run by Regeneron Pharmaceuticals at 54 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, France, Spain, Israel, Turkey (Türkiye) and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period (time frame: Up to 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.