A Study of HC006 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHC Biopharma Inc.
About this trial
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.
At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion)
Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts.
Life expectancy ≥12 weeks
Disqualifiers
Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug.
Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug.
Use of any live attenuated vaccines within 28 days.
With primary central nervous system (CNS) tumors or unstable CNS metastases.
Trial design
Design model
Sequential
Treatments tested in this trial
HC006
DrugSpecified dose on specified days
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: HC006 Dose EscalationExperimental treatment 1 intervention
Group B: HC006 Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol
Incidence of Dose Limiting Toxicities(DLTs)
Time frame
up to 24 months2
Number of participants with adverse events(AEs) as assessed by CTCAE v5.0
Incidence of adverse events(AEs)
Time frame
up to 24 months3
Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0
Incidence of Serious adverse events(SAEs)
Time frame
up to 24 months4
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
Time frame
up to 24 monthsSecondary outcomes
1
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)
Maximum serum concentration (Cmax)
Time frame
up to 24 months2
PK Parameter:Time to reach Cmax (Tmax)
Time to reach Cmax (Tmax)
Time frame
up to 24 months3
PK Parameter:Area Under the Concentration-time Curve (AUC)
Area Under the Concentration-time Curve (AUC)
Time frame
up to 24 months4
Immunogenicity
Incidence of anti-drug antibodies (ADAs) to HC006
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov