Study of CHS-114 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Newport Beach, California.

Sponsor
Coherus Oncology, Inc.
Study ID
NCT05635643
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CHS-114 — DRUG
    CHS-114
  • toripalimab — DRUG
    toripalimab-tpzi

Study Details

This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid tumors.

Key Dates

Start date
Dec 15, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1a: CHS-114 Dose Escalation
    Arm 1 monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of CHS-114 as monotherapy in up to 25 participants with advanced solid tumors, to determine the recommended dose for expansion (RDE).
  • Experimental: Arm 1b: CHS-114 Dose Expansion
    Arm 1b monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 monotherapy at 2 dose levels (potential recommended dose for expansion RDE in up to 5 participants in each dose level with Head and Neck Squamous Cell Carcinoma (HNSCC).
  • Experimental: Arm 2: CHS-114 + toripalimab Dose Escalation
    Arm 2 dose escalation will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 6 participants in each dose level with HNSCC.
  • Experimental: Arm 3: CHS-114 + toripalimab Dose Expansion
    Arm 3 dose expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-114 in combination with toripalimab at 2 RDE levels in up to 20 participants in each dose level with HNSCC.

Primary Outcome Measure

[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT) [ Time Frame: Assessed during first 21 days of treatment ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Hoag Memorial HospitalNewport BeachCalifornia92663
Patrice Jones
[email protected]
949-764-5501
Alain Mita, MD (PRINCIPAL_INVESTIGATOR)
FOMAT Medical ResearchOxnardCalifornia93030
Andrea Urrutia
[email protected]
Nawazish Khan, MD (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94305
Elizabeth Winters
[email protected]
650-723-6372
A. Dimitrios Colevas, MD (PRINCIPAL_INVESTIGATOR)
SCRI Lake Nona DDU (FL Cancer Specialists)OrlandoFlorida32827
Elizabeth Gilmore
[email protected]
904-380-2410
Cesar A Perez-Batista, MD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30308
Mosope Oyewole
[email protected]
404-778-5351
Nabil F Saba, MD (PRINCIPAL_INVESTIGATOR)
Hope & Healing Cancer ServicesHinsdaleIllinois60521
Ava Baftirovska
[email protected]
630-560-0121
Srilata Gundala, MD (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40202
Jennifer Stacy
[email protected]
502-217-5244
Rebecca Redman, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Rehan Khan
[email protected]
410-328-7496
Polly Robarts
[email protected]
410-328-4726
Ranee Mehra, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48104
Megan Hull
[email protected]
734-232-2561
Francis Worden, MD (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer CenterDetroitMichigan48201
Supraja Chalasani
[email protected]
313-576-9732
Ammar Sukari, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Samuel Williams
[email protected]
314-747-2626
Douglas Adkins, MD
[email protected]
314.747.2626
Douglas Adkins, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45219
Trisha Wise-Draper, MD
[email protected]
513-584-7698
Trisha Wise-Draper, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203
Cancer Center Trials Office
[email protected]
800-811-8480
Jennifer H Choe, MD, PhD (PRINCIPAL_INVESTIGATOR)
START- San AntonioSan AntonioTexas78229
Elizabeth Gomez
[email protected]
210-593-5994
Amita Patnaik, MD (PRINCIPAL_INVESTIGATOR)
START MountainWest Valley CityUtah84119
Marianne Herden
[email protected]
801-907-4753
Justin Call, MD
[email protected]
801-907-4753
Justin Call, MD (PRINCIPAL_INVESTIGATOR)
University of Washington/Fred Hutchinson Cancer CenterSeattleWashington98109
Ariana Dumenigo Jimenez
[email protected]
206-606-7445
Christina Rodriguez, MD (PRINCIPAL_INVESTIGATOR)

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