A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors

Launched by COHERUS BIOSCIENCES, INC. · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CHS-1000 for patients with advanced or metastatic solid tumors, which are cancers that have spread and cannot be completely removed through surgery. The main goal of the study is to see how safe and tolerable this treatment is, both on its own and when combined with another medication called toripalimab-tpzi. This trial is currently not recruiting participants, but it is designed for adults aged 65 and older who have been diagnosed with certain types of solid tumors and have either not responded to standard treatments or do not have any effective options available.

To be eligible for this trial, participants need to have a confirmed diagnosis of advanced solid tumors and at least one measurable tumor that can be evaluated. They should have also either received previous cancer treatments or be unable to tolerate them. However, participants cannot be enrolled in other clinical studies at the same time or have recently received certain types of cancer treatments or radiation therapy. If you or someone you know is considering this trial, it’s an opportunity to help researchers learn more about new treatments for difficult-to-treat cancers.

Gender

ALL

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.