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

April 25, 2024 updated by: Coherus Biosciences, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sandy Paige, Director, Clinical Operations
  • Phone Number: 800-794-5434
  • Email: spaige@coherus.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Single Agent CHS-1000
Biological: CHS-1000
Specified dose on specified days
Experimental: Part B: Combination Agents CHS-1000 + Toripalimab
Biological: CHS-1000
Specified dose on specified days
Biological: Toripalimab
Specified dose on specified days
Other Names:
  • Loqtorzi
  • Toripalimab-tpzi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 27 months
Up to approximately 27 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Concentration (Cmax)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Area Under the Concentration-time Curve (AUC)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Terminal Half-life (t1/2)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Number of Participants with Antidrug Antibodies
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Investigator-assessed Objective Response Rate (ORR)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Duration of Response (DoR)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Disease Control Rate (DCR)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Time to Response (TTP)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Progression-free Survival (PFS)
Time Frame: Up to approximately 27 months
Up to approximately 27 months
Landmark PFS Rate
Time Frame: Month 6, Month 12
Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coherus Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHS-1000-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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