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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501234-37-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Variety of mixed advanced solid tumor types |
|
| Dose Expansion A | Experimental | Triple Negative Breast Cancer (TNBC) |
|
| Dose Expansion B | Experimental | Cutaneous Squamous Cell Carcinoma (CSCC) |
|
| Dose Expansion C | Experimental | Non-Small Cell Lung Cancer (NSCLC) |
|
| Dose Expansion D | Experimental | Head and Neck Squamous Cell Carcinoma (HNSCC) |
|
| Dose Expansion E | Experimental | Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7075 | Drug | Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period | Dose escalation | Up to 6 weeks |
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) | Dose escalation | Approximately 90 days from last dose; up to 5 years |
| Incidence and severity of Adverse Events of Special Interest (AESIs) | Dose escalation | Approximately 90 days from last dose; up to 5 years |
| Incidence and severity of Serious Adverse Events (SAEs) | Dose escalation | Approximately 90 days from last dose; up to 5 years |
| Incidence and severity of grade ≥3 laboratory abnormalities | Dose escalation | Approximately 90 days from last dose; up to 5 years |
| Objective Response Rate (ORR) | Dose expansion | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of marlotamig in serum | Dose escalation and dose expansion | Up to 5 years |
| ORR | Dose escalation | Up to 5 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | United States | ||
| University of California Los Angeles (UCLA) Medical Center |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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|
| Dose Expansion F | Experimental | MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases) |
|
| Dose Expansion G | Experimental | Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI) |
|
| Dose Expansion H | Experimental | EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy |
|
| Dose Expansion I | Experimental | Third-line (3L) MSS-CRC with Active Liver Metastases |
|
| Dose Expansion J | Experimental | 3L MSS-CRC without Active Liver Metastases |
|
|
| Cemiplimab | Drug | Administered concomitantly Q3W by IV infusion or SC injection |
|
|
| Platinum-based doublet chemotherapy | Drug | Administered IV Q3W |
|
| Bevacizumab | Drug | Administered per protocol |
|
| Trifluridine-tipiracil | Drug | Administered per protocol |
|
| Progression Free Survival (PFS) | Dose escalation and dose expansion | Up to 5 years |
| Duration of Response (DOR) | Dose escalation and dose expansion | Up to 5 years |
| Disease Control Rate (DCR) | Dose escalation and dose expansion | Up to 5 years |
| Complete Response (CR) rate | Dose escalation and dose expansion | Up to 5 years |
| Overall survival (OS) | Dose escalation and dose expansion | Up to 5 years |
| Incidence of Anti-Drug Antibodies (ADA) to marlotamig | Dose escalation and dose expansion | Approximately 90 days from last dose; up to 5 years |
| Magnitude of ADA to marlotamig | Dose escalation and dose expansion | Approximately 90 days from last dose; up to 5 years |
| Incidence of ADA to cemiplimab | Dose escalation and dose expansion | Approximately 90 days from last dose; up to 5 years |
| Magnitude of ADA to cemiplimab | Dose escalation and dose expansion | Approximately 90 days from last dose; up to 5 years |
| The incidence and severity of TEAEs | Dose expansion | Approximately 90 days from last dose; up to 5 years |
| The incidence and severity of AESIs | Dose expansion | Approximately 90 days from last dose; up to 5 years |
| The incidence and severity of SAEs | Dose expansion | Approximately 90 days from last dose; up to 5 years |
| The incidence and severity of grade ≥3 laboratory abnormalities | Dose expansion | 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. | 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. | 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. | 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". | 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. | 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. | 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. | 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. | 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. | 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". | 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. | 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. | 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. | 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. | 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. | 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". | 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. | 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. | 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. | 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. | 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. | 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". | 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. | 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. | Approximately 90 days from last dose; up to 5 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| The Regents of the University of California, San Francisco | San Francisco | California | 94118 | United States |
| University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic | Aurora | Colorado | 80045 | United States |
| University of Florida Health | Gainesville | Florida | 32608 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| START Midwest - Cancer & Hematology Centers of Western Michigan, PC | Grand Rapids | Michigan | 49546 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| The Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Sarah Cannon Research Institute - 25th Ave | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Oncology And Hematology | San Antonio | Texas | 78229 | United States |
| University of Washington/Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) | Lyon | Auvergne-Rhone | 69008 | France |
| Hopital Lyon Sud | Pierre-Bénite | Auvergne-Rhône | 69310 | France |
| Centre Georges Francois Leclerc | Dijon | Bourgogne-Franche-Comté | 21034 | France |
| Institut Claudius Regaud, IUCT-Oncopole | Toulouse | Haute-Garonne | 31059 | France |
| Centre Hospitalier Universitaire (CHU) de Lille | Lille | Hauts-de-France | 59000 | France |
| Institut Bergonie | Bordeaux | New Aquitaine | 33076 | France |
| Centre Hospitalier Universitaire (CHU) de Poitiers | Poitiers | New Aquitaine | 86021 | France |
| Nantes University Hospital | Nantes | Pays de la Loire Region | 44093 | France |
| Centre Antoine Lacassagne | Nice | Provence Alpes Cote dAzur | 06189 | France |
| Hospital Paris Saint-Joseph | Paris | 75014 | France |
| Begin Army Instruction Hospital | Saint-Mandé | Île-de-France Region | 94240 | France |
| Gustave Roussy | Villejuif | Île-de-France Region | 94800 | France |
| Sheba Medical Center | Ramat Gan | Central District | 5265601 | Israel |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center | Jerusalem | 91220 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Netherlands Cancer Institute | Amsterdam | 1066 CX | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Medpolonia Sp. z o.o. | Poznan | Wielkopolska | 60-693 | Poland |
| Dom Lekarski SA | Szczecin | Zach | 70-784 | Poland |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Hospital Universitario Quiron Salud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Genesis Care Hospital San Francisco de Asis | Madrid | 28002 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario - University of Valencia | Valencia | 28040 | Spain |
| Baskent Universitesi | Yüreğir | Adana | 01120 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | 06200 | Turkey (Türkiye) |
| Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital | Istanbul | 81450 | Turkey (Türkiye) |
| Ciftlikkoy Campus Yenisehir Mersin | Mersin | 33343 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| D000068258 | Bevacizumab |
| C000613803 | trifluridine tipiracil drug combination |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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