Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Atezolizumab

Immunomodulating Agents

Liver Extracts

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab.

Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.

Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.

SRF388 will be administered by intravenous injection (IV)

SRF388

Placebo

Vienna Reichert, PhD

This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC.

After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Summaries of AEs will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of study drug (Lead-In Phase).

PFS according to RECIST v1.1 will be evaluated in patients receiving SRF388 in combination with atezolizumab plus bevacizumab compared to placebo in combination with atezolizumab plus bevacizumab (Randomized Phase).

Progression Free Survival (PFS) according to RECIST v1.1 (Lead-In Phase).

DoR will be determined according to RECIST v1.1.

DoR will be determined according to HCC mRECIST.

DCR will measure the proportion of patients who experience best overall response of complete response (CR), partial response (PR), or stable disease (SD).

OS, defined as time from study drug initiation (Lead-In) or randomization to death from any cause.

Time to response will be evaluated according to RECIST v1.1

Time to response will be evaluated according to HCC mRECIST

Summaries of AEs will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of study drug (Randomized Phase).

Percentage of patients who develop ADAs to SRF388.

Percentage of patients who develop ADAs to atezolizumab.

Serum samples will be collected and analyzed to assess the Cmax of SRF388.

Serum samples will be collected and analyzed to assess the (tmax) of SRF388.

Serum samples will be collected and analyzed to assess AUC0-last of SRF388.

Serum samples will be collected and analyzed to assess the t1/2 of SRF388.

Serum samples of atezolizumab will be collected to assess maintenance concentrations of atezolizumab

Coherus Biosciences, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma, Renal Cell

Lung Neoplasms

Kidney Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Pembrolizumab

Antibodies

Immunoglobulins

The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in up to 30 patients with advanced solid tumors.

Part B monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-388 monotherapy at the recommended phase 2 dose (RP2D) in up to 40 patients with ccRCC, up to 40 patients with HCC, and up to 40 patients with NSCLC.

Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC or HCC, or anti-PD(L)1 relapsed/refractory advanced NSCLC.

Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with anti-PD(L)1 relapsed/refractory advanced NSCLC.

CHS-388 is a fully human IgG1 antibody against IL-27. Inhibition of IL-27 with CHS-388 reduces STAT1 phosphorylation leading to increased pro-inflammatory (anti-tumor) cytokine secretion (e.g., IFN-g, TNF-a) and decreased expression of inhibitory immune checkpoint receptors (e.g., PD-L1, TIGIT, LAG3) on immune cells that may result in anticancer therapeutic activity.

CHS-388

Pembrolizumab by intravenous (IV) infusion

Toripalimab

Hillary O'Kelly, MPH

Daneng Li

Daneng Li, MD

Xiomara Menendez, RN

Lisa Harton, MS

Anthony El-Khoueiry, MD

Ria Conti

Arpita Desai, MD

Karly Griffin

Charlene Mantia, MD

Breanna Bladowski

Ulka Vaishampayan, MD

Allie Gordon

Katlyn Kraft

Daniel Morgensztern, MD

Rushka Kallicharan Smith

Saby George, MD

Natalie Lucas

Kathy Wu

Thomas Marron, MD

Moshe Ornstein, MD

Abdul Naqash, MD

Annalisa Brenneman

Leonard Appleman, MD

VICC Recruitment and Eligibility Office

Brian Rini, MD

Amy Rowell

Hans Hammers, MD

Serdar A. Gurses, PhD

Yanyan Tian, PhD

Aung Naing, MD

Angela Galindo

Amita Patnaik, MD

HyunJoo Ryu

Tae-Yong Kim, MD

Jiwon Kim

Sun Young Rha, MD

SeoJin Moon

Yoon-Koo Kang, MD

Cheng Ean Chee, MD

Shi Jian Eric Foo

Cheng Ean Cheng Ean, MD

Koho Iizuka, MD

This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of CHS-388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.

This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of CHS-388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 4 parts:

* Part A: CHS-388 monotherapy dose-escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in patients with advanced solid tumors.
* Part B: CHS-388 monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of CHS-388 monotherapy in patients with advanced or metastatic ccRCC, advanced or metastatic HCC, and advanced or metastatic NSCLC in indication specific cohorts.
* Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC,HCC, or NSCLC.
* Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with advanced NSCLC.

Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

Evaluation of DLT of CHS-388 as a monotherapy.

ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.

Evaluation of DLT of CHS-388 in combination with pembrolizumab.

Safety and tolerability of CHS-388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 5.0 or higher.

Safety and tolerability of CHS-388 will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs).

Serum concentrations of CHS-388 will be collected and analyzed to evaluate the PK of CHS-388.

Serum concentrations of CHS-388 and toripalimab will be collected and analyzed to evaluate the PK of CHS-388 and toripalimab

Pharmacodynamics of CHS-388 will be evaluated in immune cell subsets via whole blood.

DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occurs first.

DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.

PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by applicable disease criteria or death.

Serum will be collected to assess EBI3 correlation with outcomes.

Serum will be collected and assessed for the development of ADAs to CHS-388.

Serum will be collected and assessed for the development of ADAs to CHS-388 and toripalimab.

Safety and tolerability of CHS-388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs.

Safety and tolerability of CHS-388 + toripalimab will be assessed by summarizing AEs and will be based on TEAEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma	NCT05359861	Hepatocellular ...	SRF388 Atezolizumab Bevacizumab Placebo	18 Years -	Coherus Biosciences, Inc.
Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma	NCT05359861	Hepatocellular ...	SRF388 Atezolizumab Bevacizumab Placebo	18 Years -	Coherus Biosciences, Inc.
Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors	NCT04374877	Advanced Solid ... Clear Cell Rena... Hepatocellular ... Non-small Cell ...	CHS-388 Pembrolizumab Toripalimab	18 Years -	Coherus Biosciences, Inc.

Spots Global Cancer Trial Database for srf388

Every month we try and update this database with for srf388 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 srf388

Every month we try and update this database with for srf388 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 srf388 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.