Advanced or Metastatic Solid TumorsPhase 1NCT06389526
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study testing CHS-1000 and Toripalimab in people with Advanced or Metastatic Solid Tumors, run by Coherus Oncology, Inc..
Trial summary
The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- CHS-1000 and Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 30 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.
- Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.
- At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.
Who cannot join
- Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.
- Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.
- Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors
The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- CHS-1000, Toripalimab
- Keywords
- CHS-1000, Tumors, Toripalimab, ILT4, LILRB2
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS-1000Biological
Specified dose on specified days
ToripalimabBiological
Also called Loqtorzi, Toripalimab-tpzi
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Agent CHS-1000 | Experimental | Not described Receives: Biological: CHS-1000 |
| Part B: Combination Agents CHS-1000 + Toripalimab | Experimental | Not described Receives: Biological: CHS-1000; Biological: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 27 months
Secondary outcomes (10)
Maximum Observed Concentration (Cmax)
Measured: Up to approximately 27 months
Area Under the Concentration-time Curve (AUC)
Measured: Up to approximately 27 months
Terminal Half-life (t1/2)
Measured: Up to approximately 27 months
Number of Participants with Antidrug Antibodies
Measured: Up to approximately 27 months
Investigator-assessed Objective Response Rate (ORR)
Measured: Up to approximately 27 months
Duration of Response (DoR)
Measured: Up to approximately 27 months
Disease Control Rate (DCR)
Measured: Up to approximately 27 months
Time to Response (TTP)
Measured: Up to approximately 27 months
Progression-free Survival (PFS)
Measured: Up to approximately 27 months
Landmark PFS Rate
Measured: Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 Feb 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherus Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389526
- Sponsor's protocol ID
- CHS-1000-01
- Status last verified
- Sep 2024
- First submitted
- 25 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06389526
- Acronym / sponsor ID
- CHS-1000-01
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- CHS-1000, Tumors, Toripalimab, ILT4, LILRB2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 29 Apr 2024 (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.
The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Agent CHS-1000 | Experimental | Biological: CHS-1000 |
| Part B: Combination Agents CHS-1000 + Toripalimab | Experimental | Biological: CHS-1000, Biological: Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (GBM)) by tissue biopsy or archival tumor specimen. Unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (LN) involvement, and not leading to significant functional compromise as determined by surgical consult or Tumor Board.
- Participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists.
- At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.
Key exclusion criteria (4 listed)
- Concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of CHS-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study.
- Current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of CHS-1000.
- Concurrent or prior radiotherapy within 28 days prior to the 1st dose of CHS-1000 or unresolved treatment-related radiation toxicity. Limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of CHS-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
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-1000Specified dose on specified days | Biological | Part A: Single Agent CHS-1000, Part B: Combination Agents CHS-1000 + Toripalimab |
| ToripalimabAlso: Loqtorzi, Toripalimab-tpziSpecified dose on specified days | Biological | Part B: Combination Agents CHS-1000 + Toripalimab |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 27 months
10 secondary outcomes
Maximum Observed Concentration (Cmax)
Time frame: Up to approximately 27 months
Area Under the Concentration-time Curve (AUC)
Time frame: Up to approximately 27 months
Terminal Half-life (t1/2)
Time frame: Up to approximately 27 months
Number of Participants with Antidrug Antibodies
Time frame: Up to approximately 27 months
Investigator-assessed Objective Response Rate (ORR)
Time frame: Up to approximately 27 months
Duration of Response (DoR)
Time frame: Up to approximately 27 months
Disease Control Rate (DCR)
Time frame: Up to approximately 27 months
Time to Response (TTP)
Time frame: Up to approximately 27 months
Progression-free Survival (PFS)
Time frame: Up to approximately 27 months
Landmark PFS Rate
Time frame: Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHS-1000 and Toripalimab in people with Advanced or Metastatic Solid Tumors, run by Coherus Oncology, Inc..
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Paige, Senior Director, Clinical Operations (800-794-5434, spaige@coherus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 27 months). 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 19 Sep 2024.