Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

NCT06963814
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
252
clinicaltrials.gov
Lead sponsor
HC Biopharma Inc.
clinicaltrials.gov
Start date
2025-07-04
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
clinicaltrials.gov
Short title
Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-05-30
clinicaltrials.gov
First posted
2025-05-09
clinicaltrials.gov
Registry last updated
2025-07-17
clinicaltrials.gov
Primary completion date
2026-05-30
clinicaltrials.gov
Start date
2025-07-04
clinicaltrials.gov

Participants
252
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
252
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
HC Biopharma Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06963814
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06963814
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of Dose Limiting Toxicities(DLTs)

    Timeframe: up to 24 months

    Incidence of Dose Limiting Toxicities(DLTs)

  1. Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)

    Timeframe: up to 24 months

    Maximum serum concentration (Cmax)

  2. Immunogenicity

    Timeframe: up to 24 months

    Incidence of anti-drug antibodies (ADAs) to HC006

  3. Objective Response Rate (ORR) per RECIST 1.1

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  1. Fully understand this trial and voluntarily sign the informed consent form;
  2. Advanced solid tumors diagnosed by histology or cytopathology;
  3. Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;
  4. At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
  5. Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
  6. The expected survival time is more than 3 months;
  7. Adequate organ and bone marrow function
  8. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of investigational product and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).

  1. Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
  2. Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
  3. Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
  4. Conditions may significantly affect the autoimmune status;
  5. Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
  6. Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;
  7. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial;
Sources for eligibility
clinicaltrials.gov

  • Shanghai East HospitalShanghai, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)