Advanced Solid TumorPhase 1NCT05757492
Study to Evaluate Safety and PK of CHS-006 in Combination With Toripalimab in Patients With Advanced Solid Tumors
A Phase 1 study testing CHS-006 (anti-TIGIT) and toripalimab (anti-PD-1) in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by Coherus Oncology, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- CHS-006 (anti-TIGIT) and toripalimab (anti-PD-1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Apr 2023to 31 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Gabrail Cancer and Research Center
Canton, Ohio, 44718
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Florida Health Cancer Center
Orlando, Florida, 32806
Renown Institute for Cancer
Reno, Nevada, 89502
About this study
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
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])
Read the 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).
- Being tested
- CHS-006 (anti-TIGIT), toripalimab (anti-PD-1)
- Keywords
- TIGIT inhibitor, PD-1 inhibitor, Advanced Solid Tumor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS-006 (anti-TIGIT)Drug
Also called JS006
Arm A participants will receive CHS-006 administered via IV Q3W.
toripalimab (anti-PD-1)Drug
Also called CHS-007, TAB001, JS001
Arm B participants will receive toripalimab administered via IV Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Dose Optimization Phase - Arm A | Active comparator | Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W Receives: Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1) |
| Dose Optimization Phase - Arm B | Active comparator | Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W Receives: Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1) |
| Indication-specific Expansion Phase - Cohort 1 NSCLC-NS | Active comparator | NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W Receives: Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1) |
| Indication-specific Expansion Phase - Cohort 2 HCC | Active comparator | HCC participants will receive CHS-006 in combination with toripalimab Q3W Receives: Drug: CHS-006 (anti-TIGIT); Drug: toripalimab (anti-PD-1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 of study treatment through up to 90 days post last dose of study treatment
Secondary outcomes (8)
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
Measured: Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
Immunogenicity of CHS-006 and/or toripalimab
Percentage of participants who develop treatment-emergent antidrug antibodies (ADA) to CHS-006 and/or toripalimab
Measured: Measured at multiple timepoints from Day 1 of study treatment through up to 90 days post last dose of study treatment
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
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Duration of response (DoR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DoR as per RECIST v1.1
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Disease control rate (DCR) using RECIST v1.1 assessed by the investigator
Investigator-assessed DCR as per RECIST v1.1
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Time to response (TTR) using RECIST v1.1 assessed by the investigator
Investigator-assessed TTR as per RECIST v1.1
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Progression-free survival (PFS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Overall survival (OS) using RECIST v1.1 assessed by the investigator
Investigator-assessed PFS as per RECIST v1.1
Measured: Measured at multiple timepoints from Day 1 of study treatment through +/- 7 days at the completion of or premature withdrawal from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start26 Apr 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: The study was terminated for strategic reasons (not for safety concerns)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherus Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757492
- Sponsor's protocol ID
- CHS-006-01
- Status last verified
- Apr 2025
- First submitted
- 2 Jan 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05757492
- Acronym / sponsor ID
- CHS-006-01
- Keywords
- TIGIT inhibitor, PD-1 inhibitor, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated for strategic reasons (not for safety concerns)
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc., Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose Optimization Phase - Arm A | Active comparator | Drug: CHS-006 (anti-TIGIT), Drug: toripalimab (anti-PD-1)Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W |
| Dose Optimization Phase - Arm B | Active comparator | Drug: CHS-006 (anti-TIGIT), Drug: toripalimab (anti-PD-1)Advanced solid tumor participants will receive CHS-006 in combination with toripalimab Q3W |
| Indication-specific Expansion Phase - Cohort 1 NSCLC-NS | Active comparator | Drug: CHS-006 (anti-TIGIT), Drug: toripalimab (anti-PD-1)NSCLC-NS participants will receive CHS-006 in combination with toripalimab Q3W |
| Indication-specific Expansion Phase - Cohort 2 HCC | Active comparator | Drug: CHS-006 (anti-TIGIT), Drug: toripalimab (anti-PD-1)HCC participants will receive CHS-006 in combination with toripalimab Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHS-006 (anti-TIGIT)Also: JS006Arm A participants will receive CHS-006 administered via IV Q3W. | Drug | 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 |
| toripalimab (anti-PD-1)Also: CHS-007, TAB001, JS001Arm B participants will receive toripalimab administered via IV Q3W. | Drug | 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 |
Primary outcome
Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving 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 TEAEs assessed by the investigator as per CTCAE v5.0.
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
The study was stopped early (reason given: The study was terminated for strategic reasons (not for safety concerns)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHS-006 (anti-TIGIT) and toripalimab (anti-PD-1) in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by Coherus Oncology, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated for strategic reasons (not for safety concerns)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the number of participants with treatment-emergent adverse events (TEAEs) receiving 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.