Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Antibodies

Antibodies, Monoclonal

Capecitabine

Trastuzumab

Leucovorin

Fluorouracil

Oxaliplatin

Immunoglobulins

Margetuximab

Mitoguazone

Antineoplastic Agents, Immunological

margetuximab plus retifanlimab plus investigator choice of chemotherapy options.

Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle

margetuximab

Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.

Retifanlimab

Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.

Tebotelimab

Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle

Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6

Chemotherapy

XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion

mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.

Chemotherapy

Stephen L. Eck, MD, PhD

This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.

Part A is a single-arm cohort (Cohort A, 40 to 110 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab.

Part B Part 1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.

Cohort A is a single-arm cohort to evaluate safety and efficacy of margetuximab plus retifanlimab. Cohort B Part 1 is a randomized, 4-arm segment to evaluate margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab plus chemotherapy, margetuximab plus chemotherapy, vs trastuzumab plus chemotherapy.

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer

Evaluation of adverse events and serious adverse events (Cohort A)

Proportion of non MSI-H patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A )

Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A)

Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A)

Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B)

Proportion of non-MSI-high patients iwth best overall response of CR plus PR per RECIST 1.1

Zai Lab (Shanghai) Co., Ltd.

MacroGenics

Symptoms and General Pathology

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles

Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles

Enoblituzumab

Ashley L. Ward, MD

This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.

Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer

A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria..

CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria.

CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions

Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort

Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort

Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort

Time from the first dose date to the date of death from any cause, evaluated by cohort

The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD), or not evaluated (NE), per RECIST 1.1 criteria CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions, and non-PD in non-target lesions PD is defined as at least a 20% increase from nadir in the sum of diameters of target lesions or unequivocal progression in non-target lesions SD is defined as non-PD in target and non-target lesions

The highest measured concentration of enoblituzumab in the bloodstream.

The highest measured concentration of tebotelimab in the bloodstream.

The highest measured concentration of retifanlimab in the bloodstream.

The amount of enoblituzumab left in the bloodstream before the next dose is given.

The amount of tebotelimab left in the bloodstream before the next dose is given.

The amount of retifanlimab left in the bloodstream before the next dose is given.

AEs are based on physical exam, participant reports and significant abnormal laboratory values.

AEs were not collected during the survival follow up. Serious AEs (SAEs) were collected in survival follow up, if considered related to study treatment by the investigator..

Progression of cancer causing hospitalization or death is not considered an SAE, unless considered drug-related by the investigator.

Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks

Retifanlimab Cohort

Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks

Tebotelimab Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Hungary

United States

Ukraine

Poland

Bulgaria

Australia

Spain

Region of Enrollment

Chief Medical Officer

Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab

Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab

ORR of Enoblituzumab Plus Tebotelimab

Progression-free Survival (PFS)

Disease-control Rate (DCR)

Duration of Response

Overall Survival

Best Overall Response (BOR)

Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab

Participants who received Enoblituzumab and had at least 1 end of infusion PK sample. As pre-specified in the PK analysis plan, Enoblituzumab PK data from both arms of the study were combined for analysis since Enoblituzumab dose was schedule were consistent across both arms.

Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)

Participants who received tebotelimab and had at least 1 End of Infusion PK sample

Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)

Participants who received retifanlimab and had at least 1 end of infusion PK sample.

Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)

Participants who received enoblituzumab and had at least 1 pre-infusion PK sample. As pre-specified in the PK analysis plan, enoblituzumab PK data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.

Trough Concentration of Enoblituzumab (Ctrough or Cmin)

Participants who received tebotelimab and had at least 1 pre-infusion PK sample.

Trough Concentration of Tebotelimab (Ctrough or Cmin)

Participants who received retifanlimab and had at least 1 pre-infusion PK sample.

Trough Concentration of Retifanlimab (Ctrough or Cmin)

As pre-specified in the PK analysis plan, enoblituzumab ADA data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.

Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.

Only participants receiving tebotelimab were analyzed for the presence of tebotelimab ADA.

Number of Patients Who Develop ADA to Tebotelimab

Only participants receiving retifanlimab were analyzed for the presence of retifanlimab ADA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer	NCT04082364	Gastric Cancer Gastroesophagea... HER2-positive G...	margetuximab Retifanlimab Tebotelimab Trastuzumab Chemotherapy	18 Years -	MacroGenics
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer	NCT04634825	Head and Neck C... Head and Neck N... Head and Neck S...	Enoblituzumab Retifanlimab Tebotelimab	18 Years -	MacroGenics
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer	NCT04634825	Head and Neck C... Head and Neck N... Head and Neck S...	Enoblituzumab Retifanlimab Tebotelimab	18 Years -	MacroGenics

Spots Global Cancer Trial Database for tebotelimab

Every month we try and update this database with for tebotelimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tebotelimab

Every month we try and update this database with for tebotelimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tebotelimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.