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

NCT06389526 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CHS-1000-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

CHS-1000; Tumors; Toripalimab; ILT4; LILRB2

Outcome Measures

Primary Outcomes (1)

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

  Up to approximately 27 months

Secondary Outcomes (10)

• Maximum Observed Concentration (Cmax)

  Up to approximately 27 months

• Area Under the Concentration-time Curve (AUC)

  Up to approximately 27 months

• Terminal Half-life (t1/2)

  Up to approximately 27 months

• Number of Participants with Antidrug Antibodies

  Up to approximately 27 months

• Investigator-assessed Objective Response Rate (ORR)

  Up to approximately 27 months

Study Arms (2)

Part A: Single Agent CHS-1000

EXPERIMENTAL

Biological: CHS-1000

Part B: Combination Agents CHS-1000 + Toripalimab

EXPERIMENTAL

Biological: CHS-1000; Biological: Toripalimab

Interventions

CHS-1000 BIOLOGICAL

Specified dose on specified days

Part A: Single Agent CHS-1000; Part B: Combination Agents CHS-1000 + Toripalimab

Toripalimab BIOLOGICAL

Specified dose on specified days

Also known as: Loqtorzi, Toripalimab-tpzi

Part B: Combination Agents CHS-1000 + Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead

MeSH Terms

Conditions

Neoplasms

Interventions

toripalimab

Central Study Contacts

Sandy Paige, Senior Director, Clinical Operations

CONTACT

800-794-5434; spaige@coherus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share