CHS-1000

Toripalimab

Sandy Paige, Director, Clinical Operations

The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.

A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors

Coherus Biosciences, Inc.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Carcinoma, Renal Cell

Liver Neoplasms

Head and Neck Neoplasms

Carcinoma, Transitional Cell

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Adenocarcinoma

Fallopian Tube Diseases

Liver Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Fallopian Tube Cancer

All Drugs and Chemicals

Antibodies

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance.

Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.

CDX-585 is administered by infusion every 2 weeks

CDX-585

Celldex Therapeutics

Emilie Ginovker

Amy Whitaker

Phase 1 Clinical Research Team

Tara Foote

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in patients with cancer.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study.

Approximately 130 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.

A Study of CDX-585 in Patients With Advanced Malignancies

A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies

The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.

The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.

The rates of drug-related adverse events will be summarized and evaluated.

The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)

The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months

The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented

The time from start of study drug to time of progression or death, whichever occurs first

The time from start of study drug to death

CDX-585 serum concentrations will be measured at specified visits

Samples will be obtained for assessment of human anti-CDX-585

Symptoms and General Pathology

Death

Antineoplastic Agents

Antibodies, Monoclonal

Gemcitabine

Cisplatin

Immunoglobulins, Intravenous

Dose Escalation, Stage 1: JTX-8064 Monotherapy. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies.

Dose Escalation, Stage 2: JTX-8064 in combination with pimivalimab. Cohorts will enroll subjects with histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancies.

Cohort will enroll subjects with advanced/metastatic PD-1/PD-L1 (PD-(L)1)-naïve, platinum-resistant ovarian cancer.

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced clear cell renal cell carcinoma (ccRCC).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1i-experienced triple negative breast cancer (TNBC).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, PD-L1+ head and neck squamous cell carcinoma (HNSCC).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve, platinum-resistant ovarian cancer.

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced non-small cell lung cancer (NSCLC).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-experienced cutaneous squamous cell carcinoma (cSCC).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with advanced/metastatic PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS).

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with PD-(L)1i-experienced HNSCC.

JTX-8064 in combination with pimivalimab. Cohort will enroll subjects with biliary tract cancer (BTC), including intra-and extra-hepatic biliary duct cancer and cancer of the gallbladder. All subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting, must have PD-(L)1i resistance.

JTX-8064

pimivalimab

Stew Kroll

JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose (RP2D) of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i).

JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i.

Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors

Phase 1/2 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors	NCT06389526	Advanced or Met...	CHS-1000 Toripalimab	18 Years -	Coherus Biosciences, Inc.
A Study of CDX-585 in Patients With Advanced Malignancies	NCT05788484	Non-small Cell ... Gastric Cancer Head and Neck C... Ovarian Cancer Primary Periton... Fallopian Tube ... Bladder Urothel... Colorectal Canc... Esophageal Canc... Hepatic Cancer Renal Cell Carc... Cholangiocarcin... Pancreatic Canc... Other Solid Tum...	CDX-585	18 Years -	Celldex Therapeutics
Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors	NCT04669899	Cancer	JTX-8064 pimivalimab	18 Years -	Jounce Therapeutics, Inc.
Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors	NCT04669899	Cancer	JTX-8064 pimivalimab	18 Years -	Jounce Therapeutics, Inc.
A Study of CDX-585 in Patients With Advanced Malignancies	NCT05788484	Non-small Cell ... Gastric Cancer Head and Neck C... Ovarian Cancer Primary Periton... Fallopian Tube ... Bladder Urothel... Colorectal Canc... Esophageal Canc... Hepatic Cancer Renal Cell Carc... Cholangiocarcin... Pancreatic Canc... Other Solid Tum...	CDX-585	18 Years -	Celldex Therapeutics
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors	NCT06389526	Advanced or Met...	CHS-1000 Toripalimab	18 Years -	Coherus Biosciences, Inc.

Spots Global Cancer Trial Database for lilrb2

Every month we try and update this database with for lilrb2 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 lilrb2

Every month we try and update this database with for lilrb2 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 lilrb2 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.