Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Immunomodulating Agents

Tubulin Modulators

Antimitotic Agents

LM-108

Toripalimab

Eribulin

Nab paclitaxel

Biyun Wang

To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer.

LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer

A Phase II Single Center Two Cohorts Trial of LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Fudan University

Professor

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CHS-114 as monotherapy in up to 25 participants with advanced solid tumors, to determine the recommended dose for expansion (RDE).

Arm 1b monotherapy expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 monotherapy at 2 dose levels (potential recommended dose for expansion \[RDE\]) in up to 5 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).

Arm 2 combination dose expansion will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 dose recommended Phase 2 dose \[RDE\] levels in up to 6 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).

CHS-114

toripaliamab

Hillary O'Kelly

Samuel Williams

Douglas Adkins, MD

Amita Patnaik

Marianne Herden

Justin Call, MD

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in participants with advanced solid tumors, that will be conducted in 3 parts:

* Arm 1a: CHS-114 monotherapy dose-escalation portion of the study will enroll approximately 25 participants with advanced solid tumors.
* Arm 1b: CHS-114 monotherapy expansion cohort(s) will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in indication specific cohort(s). Up to approximately 10 participants will be enrolled.
* Arm 2: CHS-114 + toripalimab combination dose-escalation portion of the study will evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in combination with toripalimab in indication specific cohort(s). Up to approximately 6-12 participants will be enrolled.

Study of CHS-114 in Participants With Advanced Solid Tumors

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab

Safety and tolerability of CHS-114 as monotherapy, and in combination with toripalimab, will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher.

Serum will be collected and assessed for the development of ADAs to CHS-114

Serum concentrations of CHS-114 will be collected and analyzed to evaluate the PK of CHS-114 and in Arm 2 toripalimab.

Confirmed objective response rate (ORR) based on RECIST v1.1

Duration of response (DoR) based on RECIST v1.1. DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by RECIST v1.1 or death.

Disease control rate (DCR) based on RECIST v1.1. DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.

Progression-free survival (PFS) based on RECIST v1.1. PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by RECIST v1.1 or death.

Cellular FOX3P expression within the tumor will be collected and analyzed in participants who are undergoing pretreatment and on-treatment biopsies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer	NCT06387628	TNBC - Triple-N...	LM-108 Toripalimab Eribulin Nab paclitaxel	18 Years - 75 Years	Fudan University
Study of CHS-114 in Participants With Advanced Solid Tumors	NCT05635643	Advanced Solid ... Head and Neck S...	CHS-114 toripaliamab	18 Years -	Coherus Biosciences, Inc.
Study of CHS-114 in Participants With Advanced Solid Tumors	NCT05635643	Advanced Solid ... Head and Neck S...	CHS-114 toripaliamab	18 Years -	Coherus Biosciences, Inc.
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer	NCT06387628	TNBC - Triple-N...	LM-108 Toripalimab Eribulin Nab paclitaxel	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for ccr8

Every month we try and update this database with for ccr8 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 ccr8

Every month we try and update this database with for ccr8 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 ccr8 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.