A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHC Biopharma Inc.

About this trial

This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).

Age ≥18 and ≤75, male or female.

Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.

Participants must have at least one measurable lesion according to RECIST Version1.1

Disqualifiers

Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010; Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010;

Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;

Receipt of systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010;

Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;

Trial design

Treatments tested in this trial

  • HC010

Treatment groups

122 Participants
are divided into 2 treatment groups

Sponsors and collaborators