RecruitingPhase 1NCT06304571

A Study of HC006 in Subjects With Advanced Solid Tumors

A Phase I, Open-label, Dose-Escalation and Dose-expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of HC006 in Advanced Solid Tumor Subjects

Sponsor

HC Biopharma Inc.

Enrollment

76 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria12

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.