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Trial Title:
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT06389526
Condition:
Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
CHS-1000
Tumors
Toripalimab
ILT4
LILRB2
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CHS-1000
Description:
Specified dose on specified days
Arm group label:
Part A: Single Agent CHS-1000
Arm group label:
Part B: Combination Agents CHS-1000 + Toripalimab
Intervention type:
Biological
Intervention name:
Toripalimab
Description:
Specified dose on specified days
Arm group label:
Part B: Combination Agents CHS-1000 + Toripalimab
Other name:
Loqtorzi
Other name:
Toripalimab-tpzi
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.
Criteria for eligibility:
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 exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 15, 2025
Completion date:
May 30, 2028
Lead sponsor:
Agency:
Coherus Biosciences, Inc.
Agency class:
Industry
Source:
Coherus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389526
