Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Mitogens

Dose escalation of SYN125. Each dose level (low, medium, high) will be tested in a cohort of 3 patients. If no dose-limiting toxicity (DLT) is observed in the 3 patients, dose escalation will continue to the next SYN125 dose level.

Dose escalation of SYN125 administered with a fixed-dose of SYN004 (SYN004 will be administered immediately after SYN125 infusion is complete, if tolerated). Once cohorts with low and medium dose levels in Part A are completed and no DLTs are observed per cohort, Part B with the SYN125 low dose level + SYN004 will start and run in parallel with Part A. The high dose of SYN125 in a cohort in Part A will begin along with Part B.

SYN125

SYN004

Ding Wang, MD

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in the Treatment of Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Cancer of the Internal or External Lining of the Body.

Humans have an immune system that can protect and fight infections and abnormal cells. T-cells are a type of cell produced by the body that can attack and kill cancer cells. Unfortunately, many cancer cells have ways preventing T-cells from working properly. SYN125 and SYN004 can make T-cells work again. This is a study to find the maximum tolerated dose of SYN125 when it is used as a single treatment (Part A) for solid tumors, and when it is used as a combined treatment with a fixed dose of SYN004 (Part B), in patients with epithelial cancers with EGFR (epithelial growth factor receptor) expressions.

A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions

A Phase 1 Dose Escalation Trial of SYN125 Single Agent in Solid Tumors and in Combination With Fixed Dose SYN004 in Patients With Epithelial Cancers With EGFR Expressions.

Incidence of DLTs with single agent SYN125

Incidence of DLTs with SYN125 and fixed-dose SYN004 administered in combination

Defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)

Serum concentration time profiles (Area under the serum concentration-time curve from time zero to the last measurable concentration) of SYN125 and SYN004

Area under the serum concentration time-curve over the dosing interval of SYN125 and SYN004

Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of SYN125 and SYN004

Maximum Observed Plasma Concentration (Cmax) of SYN125 and SYN004

Time to maximum observed serum concentration (Tmax) of SYN125 and SYN004

Terminal elimination half-life (t1/2) of SYN125 and SYN004

Volume of distribution at steady-state (Vss) of SYN125 and SYN004

Synermore Biologics USA Limited

Synermore Biologics Co., Ltd.

Skin and Connective Tissue Diseases

Breast Neoplasms

Head and Neck Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Cetuximab

subjects who have received effective treatment for their cancers are eligible

John McClain, MD

A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting the growth of cancer cells thereby prolonging the life of patients who have received it. SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid some of the hypersensitivity reactions known to provoked by cetuximab.

Study Design:

In this open-label, dose escalation study, subjects will receive a single IV loading dose of SYN004 on Day 1 of the first treatment week, followed by up to 7 fixed weekly doses of SYN004. Subjects will be assigned to loading and fixed doses by dose group.

Each dose group will comprise 3 subjects and may be expanded to 6 subjects. Subjects will enter dose groups in the order in which they are enrolled. There will be no intra-subject dose adjustments.

Only 1 subject in a cohort may receive the loading dose of SYN004 on any given day; at least 1 day must elapse before the next subject in the cohort receives the loading dose.

Study SYN004-001 Dose Matrix. Three initial subjects will be enrolled followed by an additional three if specified by protocol. Dose levels are specified below.

Group 1: Loading dose: 100 mg/m2; Weekly Dose: 62.5 mg/m2. Group 2: Loading dose: 200 mg/m2; Weekly Dose: 125 mg/m2. Group 3: Loading dose: 400 mg/m2; Weekly Dose: 250 mg/m2.

After each dose of IV SYN004, subjects will be observed in the clinic for 12 hours. After the loading dose, subjects will undergo safety evaluations on Days 2, 3 and 5. Safety evaluation will also be performed on Day 1 (pre-treatment) and Day 3 of each fixed dose treatment week.

Dose-limiting toxicities (DLTs) are defined as any Grade ≥3 AE assessed by the investigator or Medical Monitor, with agreement of the Safety Review Board (SRB), as related to SYN004. Subjects with DLTs will be withdrawn from treatment. If 2 or more subjects in a dose group experience DLTs, or one subject in a dose group experiences a Grade ≥3 infusion reaction, all subjects in that dose group will be withdrawn from treatment.

Subjects in the dose groups are considered evaluable for dose escalation decisions if they receive at least 4 doses of SYN004, or discontinue SYN004 because of a DLT.

Subjects who withdraw or are terminated per protocol before receiving 4 doses of SYN004 will be replaced.

For subjects who receive at least 4 doses of SYN004, End of Study CT scans for RECIST (version 1.1) evaluation will be performed six (6) days following the final SYN004 treatment.

There will be a 28-day safety monitoring period following the final dose of SYN004 for all subjects in the study. All subjects will attend an End-of-Study Visit 28 days after the final dose of SYN004.

Subjects who complete Cycles 1 and 2, who have evidence of improvement per RECIST 1.1 (i.e., findings of complete or partial response per RECIST 1.1) and meet the other eligibility criteria will be offered up to 3 additional treatment cycles (i.e., up to 12 additional weekly doses) of SYN004 in the SYN004-001 Extension Study. During the Extension Study, subjects will receive the same fixed dose of SYN004 they received in Cycles 1 and 2.

Dose escalation will proceed according to a standard 3+3 study design.

Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors

A Phase 1, Multi-center, Open-Label Dose Escalation Study of SYN004 in Patients With Solid Tumors to Evaluate the Safety, Immunogenicity and Pharmacokinetics of SYN004 Following Administration of Eight Intravenous Doses

Blood samples will be collected for the evaluation of IgE antibodies to Galα1,3Gal

Cmax will be determined using noncompartmental methods for SYN004

Tmax will be determined using noncompartmental methods for SYN004

λz will be determined using noncompartmental methods for SYN004

t½ will be determined using noncompartmental methods for SYN004

MRT will be determined using noncompartmental methods for SYN004

AUC0-t and AUC0-∞ will be determined using noncompartmental methods for SYN004

CL will be determined using noncompartmental methods for SYN004

Vdβ and VSS will be determined using noncompartmental methods for SYN004

Measurement of objective response (OR), durability of objective response (DOR), and progression-free survival (PFS). The number and proportion of subjects who achieve objective tumor response (complete response \[CR\], partial response \[PR\], and CR+PR) or stable disease (SD) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, according to local radiological assessments from date of first administration of the investigational product to the end of the study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions	NCT04363242	Epithelial Carc... Solid Tumor	SYN125 SYN004	18 Years -	Synermore Biologics Co., Ltd.
Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors	NCT02391727	Colon Cancer, B...	SYN004	18 Years - 70 Years	Synermore Biologics Co., Ltd.

Spots Global Cancer Trial Database for syn004

Every month we try and update this database with for syn004 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for syn004

Every month we try and update this database with for syn004 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 syn004 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.