Not yet recruiting NCT06389526
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHS-1000, Toripalimab.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Biological CHS-1000
Specified dose on specified days - Biological Toripalimab
Specified dose on specified days
Primary outcome measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 27 months]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06389526 · CHS-1000-01