Study of CHS-114 in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCoherus Oncology, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Arms 1a, 1b, 2, and 3
Participants must be ≥ 18 years of age.
For Arm 1a only, locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy and for whom no available therapies are appropriate (based on the judgment of the Investigator).
At least 1 measurable lesion per RECIST 1.1.
Disqualifiers
Arms 1a, 1b, 2, and 3
Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.
History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs.
Major surgery within 4 weeks prior to Screening.
Trial design
Design model
Parallel
Treatments tested in this trial
CHS-114
DrugCHS-114
toripalimab
Drugtoripalimab-tpzi
Treatment groups
87 Participants
are divided into 4 treatment groupsGroup A: Arm 1a: CHS-114 Dose EscalationExperimental treatment 1 intervention
Group B: Arm 1b: CHS-114 Dose ExpansionExperimental treatment 1 intervention
Group C: Arm 2: CHS-114 + toripalimab Dose EscalationExperimental treatment 2 interventions
Group D: Arm 3: CHS-114 + toripalimab Dose ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
[Arms 1a, 1b, and 2] Rate of Dose Limiting Toxicity (DLT)
Evaluation of rate of DLT of CHS-114 as a monotherapy, or in combination with toripalimab
Time frame
Assessed during first 21 days of treatment2
[Arm 2] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs), anti-drug antibodies (ADA), and laboratory values.
Safety and tolerability of CHS-114 in combination with toripalimab,
Time frame
Up to 24 months3
[Arm 3] Safety and tolerability of CHS-114 in combination with toripalimab will be assessed by summarizing AEs and will be based on TEAEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher.
Safety and tolerability of CHS-114 in combination with toripalimab
Time frame
Up to 24 monthsSecondary outcomes
1
[Arms 1a and 1b] Summary of AEs based on TEAEs.
Safety and tolerability of CHS-114 as monotherapy will be assessed by summarizing AEs and will be based on TEAEs as assessed by CTCAE v5.0 or higher.
Time frame
Up to 24 months2
[Arms 1a and 1b] ADAs to CHS-114
Serum will be collected and assessed for the development of ADAs to CHS-114
Time frame
Up to 24 months3
[Arms 1a, 1b, 2, and 3] PK of CHS-114
Serum concentrations of CHS-114 will be collected and analyzed to evaluate the PK of CHS-114 and in Arms 2 and 3, toripalimab.
Time frame
Up to 24 months4
[Arms 1a, 1b, 2, and 3] Confirmed objective response rate (ORR)
Confirmed objective response rate (ORR) based on RECIST v1.1
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov