A Study of HC006 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT06304571
- Lead Sponsor
- HC Biopharma Inc.
- Brief Summary
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.
- Detailed Description
HC006, a novel therapeutic monoclonal antibody that specifically binds to human C-C motif chemokine receptor 8 (CCR8) and is designed to selectively deplete tumor-infiltrating T regulatory cells (Tregs) with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). In mouse tumor models, HC006 has demonstrated excellent antitumor activity and safety profile. This first-in-human (FIH) study will be conducted in two parts. In the Dose-Escalation part, testing will be done on up to 31 subjects to determine the maximum tolerated dose (MTD) and the recommended dose (RD). In the Dose-expansion part, we will evaluate the safety and efficacy of the recommended dose of HC006 in the treatment of advanced solid tumor subjects without standard therapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Have adequate organ function as described in the protocol.
- Agree to adopt effective contraceptive measures.
- 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.
- Have active or history of autoimmune disease or immunodeficiency disease.
- With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- With any mental or cognitive impairment that may limit their understanding, implementation.
- Major surgery within 4 weeks of study drug administration.
- Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion.
- Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma.
- Women who are pregnant or breastfeeding.
- Other protocol defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HC006 Dose Escalation HC006 - HC006 Dose Expansion HC006 -
- Primary Outcome Measures
Name Time Method Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0 up to 24 months Incidence of Serious adverse events(SAEs)
Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol up to 24 months Incidence of Dose Limiting Toxicities(DLTs)
Number of participants with adverse events(AEs) as assessed by CTCAE v5.0 up to 24 months Incidence of adverse events(AEs)
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0 up to 24 months Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 24 months Time from first dose of the investigational drug to death from any cause.
Duration of response (DOR) per RECIST 1.1 up to 24 months Time from the first evaluated CR or PR until PD or death from any cause.
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) up to 24 months Maximum serum concentration (Cmax)
progression-Free Survival (PFS) per RECIST 1.1 up to 24 months Time from first dose of the investigational drug to PD or death from any cause.
Disease Control Rate (DCR) per RECIST 1.1 up to 24 months The sum of proportions of subjects who achieved CR, PR, and SD in imaging evaluation.
Time To Response (TTR) per RECIST 1.1 up to 24 months Time from first dose of the investigational drug to the first tumor evaluation of CR or PR.
PK Parameter:Area Under the Concentration-time Curve (AUC) up to 24 months Area Under the Concentration-time Curve (AUC)
Objective Response Rate (ORR) per RECIST 1.1 up to 24 months The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
PK Parameter:Time to reach Cmax (Tmax) up to 24 months Time to reach Cmax (Tmax)
Immunogenicity up to 24 months Incidence of anti-drug antibodies (ADAs) to HC006
Time to progression (TTP) per RECIST 1.1 up to 24 months Time from first dose of the investigational drug to the tumor evaluation of PD.
Trial Locations
- Locations (1)
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China