Advanced or Metastatic Solid Tumors
Conditions
Keywords
CHS-1000, Tumors, Toripalimab, ILT4, LILRB2
Brief 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.
Interventions
BIOLOGICALCHS-1000
Specified dose on specified days
BIOLOGICALToripalimab
Specified dose on specified days
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 27 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to Response (TTP) | Up to approximately 27 months |
| Progression-free Survival (PFS) | Up to approximately 27 months |
| Landmark PFS Rate | Month 6, Month 12 |
| Maximum Observed Concentration (Cmax) | Up to approximately 27 months |
| Area Under the Concentration-time Curve (AUC) | Up to approximately 27 months |
| Terminal Half-life (t1/2) | Up to approximately 27 months |
| Number of Participants with Antidrug Antibodies | Up to approximately 27 months |
| Investigator-assessed Objective Response Rate (ORR) | Up to approximately 27 months |
| Duration of Response (DoR) | Up to approximately 27 months |
| Disease Control Rate (DCR) | Up to approximately 27 months |
Contacts
Primary ContactSandy Paige, Senior Director, Clinical Operations
Outcome results
None listed