Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

All Drugs and Chemicals

Antibodies

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

The initial cohorts will enroll sequentially as single participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design. Additional participants will be recruited into the PK/PD expansion cohorts at dose levels deemed safe during dose escalation. Once a tolerated dose has been established participants will be recruited into tumour-specific expansion cohorts.

Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity.

FS222

invoX Clinical Trials

Marina Maglakelidze, MD

Laurentia Nicoleta Gales, MD

Alexandru Grigorescu, MD

Tudor Ciuleanu, MD

Ignacio Melero Bermejo, Ldo.

Guzman Alonso Casal, MD

Elena Garralda Cabanas, Ldo.

Javier Garcia Corbacho, Ldo.

Marc Cucurull Salamero

Delvys Rodriguez-Abreu, MD

Victor Moreno, MD

Gillermo de Velasco Oria de Rueda, Ldo.

Valentina Boni, MD

Mariano Provencio Pulla, MD

Teresa Garcia Manrique, MD

Andrés Cervantes Ruiperez, Ldo.

This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

FS222 First in Human Study in Patients With Advanced Malignancies

A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies

Safety and tolerability will be evaluated by collection of AEs and SAEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

invoX Pharma Limited

Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels.

EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.

EMB-09

Shuqi Zeng, MD.

Di Hu

Vinod Ganju

Adrian Lee

Adnan Nagrial

Jian Zhang

This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.

This is a phase I, multi-center, open label, multiple dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.

Single Group Assignment Dose escalation followed by Cohort Expansion Phase at the RP2D.

A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.

A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors

Incidence of dose interruptions of EMB-09 during treatment as a measure of tolerability.

Actual amount of drug taken by patients divided by the planned amount.

The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.

Blood samples for serum PK analysis will be obtained (AUC).

Blood samples for serum PK analysis will be obtained (Cmax)

Blood samples for serum PK analysis will be obtained (Ctrough)

Blood samples for serum PK analysis will be obtained (Css, avg).

Blood samples for serum PK analysis will be obtained (T1/2)

Blood samples for serum PK analysis will be obtained (CL).

Blood samples for serum PK analysis will be obtained (Vss).

Preliminary anti-tumor activity of EMB-09 will be obtained. (DOR)

Antibodies to EMB-09 will be assessed to evaluate potential immunogenicity.

Shanghai EpimAb Biotherapeutics Co., Ltd.

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Melanoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Lung Neoplasms

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Adenocarcinoma

Head and Neck Neoplasms

Transitional Cell Carcinoma

Bile Duct Cancer

Phase 1 Dose Escalation (Cohort -1): Subjects received NC318 IV at 8mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation (Cohort 1): Subjects received NC318 IV at 24mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation/Safety Expansion (Cohort 2): Subjects received NC318 IV at 80mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation/Safety Expansion (Cohort 3): Subjects received NC318 IV at 240mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation/Safety Expansion (Cohort 4): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation (Cohort 5): Subjects received NC318 IV at 800mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 1 Dose Escalation (Cohort 6): Subjects received NC318 IV at 1600mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 2 Dose Expansion (400mg): Subjects received NC318 IV at 400mg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Phase 2 Dose Expansion (800mg): Subjects received NC318 IV at 800mg QW for 8 weeks, then Q2W thereafter until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

NC318 is an experimental antibody drug that may make the immune response more active against cancer.

NC318

Han Myint, MD

This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.

Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC318 at the RP2D utilizing a Simon 2-stage design.

A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

The number of participants who have had at least one TEAE during the study.

To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

To evaluate progression-free survival (PFS), defined as the time from the first dose of NC318 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

To evaluate overall survival (OS), defined as the time from the first dose of NC318 to death due to any cause.

To evaluate the Maximum Plasma Concentration (Cmax) of NC318

To evaluate the Area Under the Curve (AUC) of NC318

To evaluate the half-life (t1/2) of NC318

NextCure, Inc.

The severity of AEs will be assessed using NCI CTCAE v5.0 Grades 1 through 4. The NCI CTCAE v5.0 severity of Grade 5 will not be used; AEs resulting in death will be graded accordingly using Grades 1 through 4 and have the outcome noted as fatal.

NC318 8mg

NC318 24mg

NC318 80mg

NC318 240mg

NC318 400mg

NC318 800mg

NC318 1600mg

Dose Expansion: 400mg Q2W

Dose Expansion: 800mg QW

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The full analysis set (FAS) includes all subjects enrolled in the study who received at least one full dose of NC318.

Chief Medical Officer

The Safety Analysis Set (SAS) will include all the subjects who receive any amount of study drug.

Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Overall Survival (OS)

The PK analysis set (PAS) will include all the subjects whose blood samples are collected for PK analysis. PK analysis only took place during the dose escalation portion of the study.

Maximum Plasma Concentration (Cmax) of NC318

Area Under the Curve (AUC) of NC318

Half-life (t1/2) of NC318

Overall Study

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

The initial cohorts will enroll sequentially as single-participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design followed by an expansion cohort of participants with SCCHN and an expansion SCCHN cohort in combination with Paclitaxel.

Dosing of participants will occur intravenously (IV) weekly in 3-week treatment cycles until iCPD (i.e., immune confirmed progressive disease), unacceptable toxicity, or discontinuation.

FS118

Dosing on Days 1, 8 and 15 of each 28 day cycle in combination with FS118 given on days 1, 8, 15 and 22 of each 28 day cycle.

This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.

A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies

A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies

Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03

Blood samples for serum PK analysis will be obtained (concentrations measured in mcg/mL)

Blood samples for serum PK analysis will be obtained (Cmax measured in mcg/mL)

Blood samples for serum PK analysis will be obtained (Tmax measured in hours)

Blood samples for serum PK analysis will be obtained (Ctrough measured in mcg/mL)

Blood samples for serum PK analysis will be obtained (AUC measured in d.mcg/mL)

Blood samples for serum PK analysis will be obtained (CL measured in mL/day)

Incidence of FS118 immunogenicity will include ADA detection and analysis (incidence measured in titre)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FS222 First in Human Study in Patients With Advanced Malignancies	NCT04740424	Advanced Cancer Metastatic Canc...	FS222	18 Years -	invoX Pharma Limited
A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.	NCT05263180	Advanced Solid ...	EMB-09	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors	NCT03665285	Advanced or Met... Lung Cancer Breast Cancer Head and Neck S... Endometrial Can... Melanoma CRC Urothelial Carc... Cholangiocarcin...	NC318	18 Years -	NextCure, Inc.
A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies	NCT03440437	Advanced Cancer Metastatic Canc... Squamous Cell C...	FS118 Paclitaxel	18 Years -	invoX Pharma Limited
A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.	NCT05263180	Advanced Solid ...	EMB-09	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.

Spots Global Cancer Trial Database for cohort expansion