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

Advanced or Metastatic Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389526
• Other study ID #: CHS-1000-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 1, 2024
• Est. completion date: January 30, 2028

Study information

• Verified date: April 2024
• Source: Coherus Biosciences, Inc.
• Contact: Sandy Paige, Director, Clinical Operations
• Phone: 800-794-5434
• Email: spaige[@]coherus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Biological:
• CHS-1000
Specified dose on specified days
• Toripalimab
Specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coherus Biosciences, Inc.

Outcome

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