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NCT Number: NCT06389526

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHS-1000

Biological

Specified dose on specified days

Toripalimab

Biological

Specified dose on specified days

Other names: Loqtorzi, Toripalimab-tpzi

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 27 months

Secondary outcomes

  1. Maximum Observed Concentration (Cmax)

    Time frame: Up to approximately 27 months

  2. Area Under the Concentration-time Curve (AUC)

    Time frame: Up to approximately 27 months

  3. Terminal Half-life (t1/2)

    Time frame: Up to approximately 27 months

  4. Number of Participants with Antidrug Antibodies

    Time frame: Up to approximately 27 months

  5. Investigator-assessed Objective Response Rate (ORR)

    Time frame: Up to approximately 27 months

  6. Duration of Response (DoR)

    Time frame: Up to approximately 27 months

  7. Disease Control Rate (DCR)

    Time frame: Up to approximately 27 months

  8. Time to Response (TTP)

    Time frame: Up to approximately 27 months

  9. Progression-free Survival (PFS)

    Time frame: Up to approximately 27 months

  10. Landmark PFS Rate

    Time frame: Month 6, Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Sandy Paige, Senior Director, Clinical Operations

CONTACT

[email protected]

800-794-5434

Sponsors and collaborators

Lead sponsor

Coherus Oncology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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