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NCT Number: NCT04626635

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL), Lyon, Auvergne-Rhone, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  • 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

Treatment and study plan

REGN7075

Drug

Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)

Other names: marlotamig

cemiplimab

Drug

Administered concomitantly Q3W by IV infusion or SC injection

Other names: REGN2810, Libtayo

Platinum-based doublet chemotherapy

Drug

Administered IV Q3W

Bevacizumab

Drug

Administered per protocol

Trifluridine-tipiracil

Drug

Administered per protocol

Primary outcomes

  1. The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period

    Time frame: Up to 6 weeks

    Dose escalation

  2. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation

  3. Incidence and severity of Adverse Events of Special Interest (AESIs)

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation

  4. Incidence and severity of Serious Adverse Events (SAEs)

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation

  5. Incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation

  6. Objective Response Rate (ORR)

    Time frame: Up to 5 years

    Dose expansion

Secondary outcomes

  1. Concentrations of marlotamig in serum

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  2. ORR

    Time frame: Up to 5 years

    Dose escalation

  3. Progression Free Survival (PFS)

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  4. Duration of Response (DOR)

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  5. Disease Control Rate (DCR)

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  6. Complete Response (CR) rate

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  7. Overall survival (OS)

    Time frame: Up to 5 years

    Dose escalation and dose expansion

  8. Incidence of Anti-Drug Antibodies (ADA) to marlotamig

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation and dose expansion

  9. Magnitude of ADA to marlotamig

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation and dose expansion

  10. Incidence of ADA to cemiplimab

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation and dose expansion

  11. Magnitude of ADA to cemiplimab

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose escalation and dose expansion

  12. The incidence and severity of TEAEs

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose expansion

  13. The incidence and severity of AESIs

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose expansion

  14. The incidence and severity of SAEs

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose expansion

  15. The incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Approximately 90 days from last dose; up to 5 years

    Dose expansion

  16. 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

    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.

  17. 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

    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.

  18. 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

    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.

  19. 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

    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".

  20. 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

    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.

  21. Patient reported Quality of Life (QoL) per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  22. Patient reported symptoms per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  23. Patient reported symptoms per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  24. Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  25. Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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".

  26. Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  27. Patient reported symptoms per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  28. Patient reported functioning per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  29. Patient reported functioning per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  30. Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  31. Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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".

  32. Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  33. Patient reported functioning per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  34. Patient reporting general health status per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  35. Patient reporting general health status per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  36. 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

    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.

  37. Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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".

  38. Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

  39. Patient reporting general health status per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

    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.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Acronym: COMBINE-EGFR-1

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2020
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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