search
Back to results

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors

Primary Purpose

Advanced Solid Tumor, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHS-006 (anti-TIGIT)
toripalimab (anti-PD-1)
Sponsored by
Coherus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring TIGIT inhibitor, PD-1 inhibitor, Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females, ≥18 years old; Histopathologically or cytologically confirmed advanced solid tumor (except pancreatic) with disease progression after at least 1 prior line of standard therapy (Dose Optimization phase); Tumor-specific criteria (Indication-specific Expansion phase): NSCLC-NS (without sensitizing EGFR/ALK/ROS-1/MET mutations) 2nd line plus (2L+): has received and progressed on at least 1 prior chemotherapy regimen. Prior treatment with both anti-PD-1 therapy and platinum-based chemotherapy either concurrently or sequentially are eligible. Hepatocellular carcinoma (HCC) 2L+: has received and progressed on at least 1 prior anticancer regimen. Participants with prior treatment with an anti-PD-1 or PD-L1 agent are eligible. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and expected survival ≥12 weeks; At least 1 measurable lesion per RECIST v1.1; Adequate organ and marrow function Exclusion Criteria: Current or prior use of systemic anticancer therapy, including but not limited to chemotherapy, immunotherapy, biologic therapy, hormone therapy, and targeted therapy, within 28 days prior to the 1st dose of CHS-006; NSCLC participants with genomic mutations (e.g., EGFR, ALK, ROS-1, MET, etc.) for which FDA-approved targeted therapies are available or require progression on appropriate prior to enrollment; Prior exposure to monoclonal antibodies (mAbs) targeting TIGIT or any of its ligands, including CD155, CD112, or CD113; Major surgery within 28 days prior to the 1st dose of CHS-006 or still recovering from prior surgery; Symptomatic or untreated central nervous system (CNS) metastases; Use of therapeutic immunosuppressive medication within 28 days prior to the 1st planned dose of CHS-006; Receipt of live, attenuated vaccination within 30 days prior to the 1st dose of CHS- 006; History of active autoimmune disease within the past 2 years, with the following exceptions: vitiligo, alopecia, endocrinopathies controlled by hormone replacement therapy, rheumatoid arthritis and other arthropathies that have not required immunosuppression other than nonsteroidal anti-inflammatory agents, celiac disease controlled by diet, or psoriasis controlled with topical medication; Participants with another active solid tumor that has not been curatively treated.

Sites / Locations

  • Renown Institute for CancerRecruiting
  • Gabrail Cancer and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dose Optimization Phase - Arm A

Dose Optimization Phase - Arm B

Indication-specific Expansion Phase - Cohort 1 NSCLC-NS

Indication-specific Expansion Phase - Cohort 2 HCC

Arm Description

Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W

Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W

NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W

HCC participants will receive CHS-006 in combination with toripalimab Q3W

Outcomes

Primary Outcome Measures

Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving CHS-006 administered in combination with toripalimab
Assessed by number of participants with TEAEs assessed by the investigator as per CTCAE v5.0.

Secondary Outcome Measures

Description of the PK profile of CHS-006 in combination with toripalimab
Assessed by serum concentration of CHS-006 and toripalimab as determined by validated assays
Immunogenicity of CHS-006 and/or toripalimab
Percentage of participants who develop treatment-emergent antidrug antibodies (ADA) to CHS-006 and/or toripalimab
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the investigator
Investigator-assessed ORR as per RECIST v1.1
Duration of response (DoR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DoR as per RECIST v1.1
Disease control rate (DCR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DCR as per RECIST v1.1
Time to response (TTR) using RECIST v1.1 assessed by the investigator
Investigator-assessed TTR as per RECIST v1.1
Progression-free survival (PFS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1
Overall survival (OS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1

Full Information

First Posted
January 2, 2023
Last Updated
May 5, 2023
Sponsor
Coherus Biosciences, Inc.
Collaborators
Medpace, Inc., Shanghai Junshi Bioscience Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05757492
Brief Title
Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
Official Title
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CHS-006, as Monotherapy and in Combination With Toripalimab, in Participants With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coherus Biosciences, Inc.
Collaborators
Medpace, Inc., Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase 1 open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CHS-006 in combination with toripalimab in 2 phases. Phase 1 (Dose Optimization phase) will explore 2 different dose combinations in participants with advanced/metastatic solid tumors (except pancreatic) and Phase 2 (Indication-specific Expansion phase) will use one selected dose in specific tumor types (non-small cell lung cancer-non squamous [NSCLC-NS] and Hepatocellular carcinoma [HCC])
Detailed Description
The Dose Optimization phase will enroll participants with advanced/metastatic solid tumors (except pancreatic). Up to 20 participants will be randomized into two dosing arms. Two different primary advanced solid tumors have been selected for investigation of antitumor activity in the Indication-specific Expansion phase. Up to 40 participants will be enrolled into each Indication-specific Expansion phase cohort. All participants in both phases will receive CHS-006 in combination with toripalimab intravenously (IV) every 3 weeks (Q3W).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
Keywords
TIGIT inhibitor, PD-1 inhibitor, Advanced Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This is a Phase 1, open-label, multiple-phase, multiple phase study. Participants within the advanced solid tumor dose optimization phase will be assigned to one of two dosing arms. After one CHS-006 dose has been selected from Phase 1, Phase 2 participants will be dosed with that dose in combination with toripalimab.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Optimization Phase - Arm A
Arm Type
Active Comparator
Arm Description
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
Arm Title
Dose Optimization Phase - Arm B
Arm Type
Active Comparator
Arm Description
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
Arm Title
Indication-specific Expansion Phase - Cohort 1 NSCLC-NS
Arm Type
Active Comparator
Arm Description
NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W
Arm Title
Indication-specific Expansion Phase - Cohort 2 HCC
Arm Type
Active Comparator
Arm Description
HCC participants will receive CHS-006 in combination with toripalimab Q3W
Intervention Type
Drug
Intervention Name(s)
CHS-006 (anti-TIGIT)
Other Intervention Name(s)
JS006
Intervention Description
Arm A participants will receive CHS-006 administered via IV Q3W.
Intervention Type
Drug
Intervention Name(s)
toripalimab (anti-PD-1)
Other Intervention Name(s)
CHS-007, TAB001, JS001
Intervention Description
Arm B participants will receive toripalimab administered via IV Q3W.
Primary Outcome Measure Information:
Title
Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving CHS-006 administered in combination with toripalimab
Description
Assessed by number of participants with TEAEs assessed by the investigator as per CTCAE v5.0.
Time Frame
Day 1 of study treatment through up to 90 days post last dose of study treatment
Secondary Outcome Measure Information:
Title
Description of the PK profile of CHS-006 in combination with toripalimab
Description
Assessed by serum concentration of CHS-006 and toripalimab as determined by validated assays
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
Title
Immunogenicity of CHS-006 and/or toripalimab
Description
Percentage of participants who develop treatment-emergent antidrug antibodies (ADA) to CHS-006 and/or toripalimab
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
Title
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the investigator
Description
Investigator-assessed ORR as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Title
Duration of response (DoR) using RECIST v1.1 assessed by the investigator
Description
Investigator-assessed DoR as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Title
Disease control rate (DCR) using RECIST v1.1 assessed by the investigator
Description
Investigator-assessed DCR as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Title
Time to response (TTR) using RECIST v1.1 assessed by the investigator
Description
Investigator-assessed TTR as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Title
Progression-free survival (PFS) using RECIST v1.1 assessed by the investigator
Description
Investigator-assessed PFS as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Title
Overall survival (OS) using RECIST v1.1 assessed by the investigator
Description
Investigator-assessed PFS as per RECIST v1.1
Time Frame
Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, ≥18 years old; Histopathologically or cytologically confirmed advanced solid tumor (except pancreatic) with disease progression after at least 1 prior line of standard therapy (Dose Optimization phase); Tumor-specific criteria (Indication-specific Expansion phase): NSCLC-NS (without sensitizing EGFR/ALK/ROS-1/MET mutations) 2nd line plus (2L+): has received and progressed on at least 1 prior chemotherapy regimen. Prior treatment with both anti-PD-1 therapy and platinum-based chemotherapy either concurrently or sequentially are eligible. Hepatocellular carcinoma (HCC) 2L+: has received and progressed on at least 1 prior anticancer regimen. Participants with prior treatment with an anti-PD-1 or PD-L1 agent are eligible. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and expected survival ≥12 weeks; At least 1 measurable lesion per RECIST v1.1; Adequate organ and marrow function Exclusion Criteria: Current or prior use of systemic anticancer therapy, including but not limited to chemotherapy, immunotherapy, biologic therapy, hormone therapy, and targeted therapy, within 28 days prior to the 1st dose of CHS-006; NSCLC participants with genomic mutations (e.g., EGFR, ALK, ROS-1, MET, etc.) for which FDA-approved targeted therapies are available or require progression on appropriate prior to enrollment; Prior exposure to monoclonal antibodies (mAbs) targeting TIGIT or any of its ligands, including CD155, CD112, or CD113; Major surgery within 28 days prior to the 1st dose of CHS-006 or still recovering from prior surgery; Symptomatic or untreated central nervous system (CNS) metastases; Use of therapeutic immunosuppressive medication within 28 days prior to the 1st planned dose of CHS-006; Receipt of live, attenuated vaccination within 30 days prior to the 1st dose of CHS- 006; History of active autoimmune disease within the past 2 years, with the following exceptions: vitiligo, alopecia, endocrinopathies controlled by hormone replacement therapy, rheumatoid arthritis and other arthropathies that have not required immunosuppression other than nonsteroidal anti-inflammatory agents, celiac disease controlled by diet, or psoriasis controlled with topical medication; Participants with another active solid tumor that has not been curatively treated.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hillary O'Kelly, MPH
Phone
805-551-1699
Email
HOKelly@Coherus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Page
Email
SPaige@Coherus.com
Facility Information:
Facility Name
Renown Institute for Cancer
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Preciado
Email
Lisa.Preciado@renown.org
First Name & Middle Initial & Last Name & Degree
Lee Schwartzberg, MD
Facility Name
Gabrail Cancer and Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Smith, RN
Phone
330-492-3345
Ext
208
Email
CSmith@GabrailCancerCenter.com
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail, MD

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors

We'll reach out to this number within 24 hrs