To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of HC006 in Subjects With Advanced Solid Tumors
NCT ID:
NCT06304571
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HC006
Description:
Specified dose on specified days
Arm group label:
HC006 Dose Escalation
Arm group label:
HC006 Dose Expansion
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo, MD
Email:
pattrickguo@gmail.com
Start date:
February 27, 2024
Completion date:
July 16, 2026
Lead sponsor:
Agency:
HC Biopharma Inc.
Agency class:
Industry
Source:
HC Biopharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304571