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

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ClinicalTrials.gov Identifier: NCT05757492
Recruitment Status : Not yet recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
Sponsor:
Collaborators:
Medpace, Inc.
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Study Description
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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])

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Non-Small Cell Lung Cancer Hepatocellular Carcinoma Drug: CHS-006 (anti-TIGIT) Drug: toripalimab (anti-PD-1) Phase 1 Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 14, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dose Optimization Phase - Arm A
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
 Drug: CHS-006 (anti-TIGIT)
Arm A participants will receive CHS-006 administered via IV Q3W.
Other Name: JS006

Drug: toripalimab (anti-PD-1)
Arm B participants will receive toripalimab administered via IV Q3W.
Other Name: CHS-007, TAB001, JS001
Active Comparator: Dose Optimization Phase - Arm B
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
 Drug: CHS-006 (anti-TIGIT)
Arm A participants will receive CHS-006 administered via IV Q3W.
Other Name: JS006

Drug: toripalimab (anti-PD-1)
Arm B participants will receive toripalimab administered via IV Q3W.
Other Name: CHS-007, TAB001, JS001
Active Comparator: Indication-specific Expansion Phase - Cohort 1 NSCLC-NS
NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W
 Drug: CHS-006 (anti-TIGIT)
Arm A participants will receive CHS-006 administered via IV Q3W.
Other Name: JS006

Drug: toripalimab (anti-PD-1)
Arm B participants will receive toripalimab administered via IV Q3W.
Other Name: CHS-007, TAB001, JS001
Active Comparator: Indication-specific Expansion Phase - Cohort 2 HCC
HCC participants will receive CHS-006 in combination with toripalimab Q3W
 Drug: CHS-006 (anti-TIGIT)
Arm A participants will receive CHS-006 administered via IV Q3W.
Other Name: JS006

Drug: toripalimab (anti-PD-1)
Arm B participants will receive toripalimab administered via IV Q3W.
Other Name: CHS-007, TAB001, JS001


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of safety and tolerability of CHS-006 administered in combination with toripalimab [ Time Frame: Day 1 of study treatment through up to 90 days post last dose of study treatment ]
    Assessed by number of participants with treatment-emergent adverse events (TEAEs) assessed by the investigator as per CTCAE v5.0.


Secondary Outcome Measures :
  1. Description of the PK profile of CHS-006 in combination with toripalimab [ Time Frame: Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment ]
    Assessed by serum concentration of CHS-006 and toripalimab as determined by validated assays

  2. Immunogenicity of 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 ]
    Percentage of participants who develop treatment-emergent antidrug antibodies (ADA) to CHS-006 and/or toripalimab

  3. Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed ORR as per RECIST v1.1

  4. Duration of response (DoR) using RECIST v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed DoR as per RECIST v1.1

  5. Disease control rate (DCR) using RECIST v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed DCR as per RECIST v1.1

  6. Time to response (TTR) using RECIST v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed TTR as per RECIST v1.1

  7. Progression-free survival (PFS) using RECIST v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed PFS as per RECIST v1.1

  8. Overall survival (OS) using RECIST v1.1 assessed by the investigator [ 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 ]
    Investigator-assessed PFS as per RECIST v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757492


Contacts
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Contact: Hassan Danesi, MD, MBA 800-794-5434 HDanesi@Coherus.com
Contact: Hillary O'Kelly, MPH 805-551-1699 HOKelly@Coherus.com

Locations
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United States, Ohio
Gabrail Cancer and Research Center
Canton, Ohio, United States, 44718
Contact: Carrie Smith, RN    330-492-3345 ext 208    CSmith@GabrailCancerCenter.com   
Principal Investigator: Nashat Gabrail, MD         
Sponsors and Collaborators
Coherus Biosciences, Inc.
Medpace, Inc.
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05757492    
Other Study ID Numbers: CHS-006-01
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coherus Biosciences, Inc.:
TIGIT inhibitor
PD-1 inhibitor
Advanced Solid Tumor
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Hepatocellular
Neoplasms by Site
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases