Testing HC006 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of HC006, a novel monoclonal antibody targeting CCR8, in patients with advanced solid tumors. It is a first-in-human study that consists of two parts: a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to assess the efficacy of the recommended dose. The study aims to selectively deplete tumor-infiltrating T regulatory cells to enhance antitumor responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: langxi Zhang, PhD
• Email: langxi.zhang@btyy.com
• Phone: 00-86-021-50433368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.