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Monoclonal Antibodies
CHS-006 + Toripalimab for Solid Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Coherus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of study treatment through up to 90 days post last dose of study treatment
Awards & highlights
Study Summary
This trial will investigate safe & effective doses of a new drug combo to treat advanced/metastatic solid cancers, except pancreatic, like NSCLC-NS & HCC.
Who is the study for?
This trial is for adults (18+) with advanced solid tumors, including non-small cell lung cancer and liver cancer. Participants must have progressed after prior treatments but can't have had TIGIT-targeting therapy or recent surgeries, immunosuppressants, vaccinations, or systemic anticancer therapies. They should not have certain genetic mutations in NSCLC or active autoimmune diseases.Check my eligibility
What is being tested?
The study tests the safety and effects of CHS-006 combined with toripalimab on patients with advanced tumors. It has two phases: Phase 1 finds the best dose combination; Phase 2 expands to specific cancers using that dose to further assess effectiveness.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to both drugs' action on the immune system, infusion-related symptoms like fever or chills, fatigue, possible organ inflammation, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of study treatment through up to 90 days post last dose of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of study treatment through up to 90 days post last dose of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving CHS-006 administered in combination with toripalimab
Secondary outcome measures
Description of the PK profile of CHS-006 in combination with toripalimab
Disease control rate (DCR) using RECIST v1.1 assessed by the investigator
Duration of response (DoR) using RECIST v1.1 assessed by the investigator
+5 moreTrial Design
4Treatment groups
Active Control
Group I: Indication-specific Expansion Phase - Cohort 2 HCCActive Control2 Interventions
HCC participants will receive CHS-006 in combination with toripalimab Q3W
Group II: Indication-specific Expansion Phase - Cohort 1 NSCLC-NSActive Control2 Interventions
NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W
Group III: Dose Optimization Phase - Arm AActive Control2 Interventions
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
Group IV: Dose Optimization Phase - Arm BActive Control2 Interventions
Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W
Find a Location
Who is running the clinical trial?
Coherus Biosciences, Inc.Lead Sponsor
11 Previous Clinical Trials
3,254 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,593 Total Patients Enrolled
Shanghai Junshi Bioscience Co., Ltd.OTHER
112 Previous Clinical Trials
27,221 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immunosuppressive drugs in the last 28 days.I haven't taken any cancer treatments like chemotherapy or immunotherapy in the last 28 days.My liver cancer has worsened after at least one treatment, including treatments targeting PD-1 or PD-L1.My NSCLC has worsened after at least one chemotherapy, and I've had anti-PD-1 and platinum-based treatments.I haven't had an active autoimmune disease in the last 2 years, except for conditions like vitiligo or controlled rheumatoid arthritis.I have brain metastases that are causing symptoms or have not been treated.I haven't had major surgery in the last 28 days or am still recovering from one.I have not received a live vaccine in the last 30 days.I am 18 years old or older.My organs and bone marrow are working well.My NSCLC has specific mutations and I've tried all suitable FDA-approved treatments.I have not been treated with drugs targeting TIGIT or its related proteins.I have another cancer that hasn't been treated to cure.My advanced cancer, not pancreatic, has worsened after treatment.I am mostly active and my doctor expects me to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Indication-specific Expansion Phase - Cohort 2 HCC
- Group 2: Indication-specific Expansion Phase - Cohort 1 NSCLC-NS
- Group 3: Dose Optimization Phase - Arm A
- Group 4: Dose Optimization Phase - Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project still accepting participants?
"The study is no longer actively recruiting, as indicated on clinicaltrials.gov - it was first posted in March of 2023 and has since been amended twice. Nonetheless, there are still 3711 other trials that require participants."
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