Clinical trial NCT06389526: A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Keywords: CHS-1000
Tumors
Toripalimab
ILT4
LILRB2
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 27 months
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to approximately 27 months
measure: Area Under the Concentration-time Curve (AUC)
timeFrame: Up to approximately 27 months
measure: Terminal Half-life (t1/2)
timeFrame: Up to approximately 27 months
measure: Number of Participants with Antidrug Antibodies
timeFrame: Up to approximately 27 months
measure: Investigator-assessed Objective Response Rate (ORR)
timeFrame: Up to approximately 27 months
measure: Duration of Response (DoR)
timeFrame: Up to approximately 27 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 27 months
measure: Time to Response (TTP)
timeFrame: Up to approximately 27 months
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 27 months
measure: Landmark PFS Rate
timeFrame: Month 6, Month 12
Other outcomes:
Locations:
Study officials:
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