> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-hc006-in-combination-with-a-pd-1-inhibitor-in-84f0f689-a273-4e67-82f8-34b0e30f6572 > Record changed: 2026-10-13 # Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors NCT06963814 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Participants 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Lead sponsor HC Biopharma Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Start date 2025-07-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Short title** Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Dates **Completion date** 2027-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **First posted** 2025-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Registry last updated** 2025-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Primary completion date** 2026-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Start date** 2025-07-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Size and sites **Participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Planned participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Lead sponsor** HC Biopharma Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Identifiers **Registry ID** NCT06963814 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **ClinicalTrials.gov ID** NCT06963814 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Outcomes ### Primary outcomes 1. Incidence of Dose Limiting Toxicities(DLTs) Timeframe: up to 24 months Incidence of Dose Limiting Toxicities(DLTs) ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 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). ### Exclusion criteria 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Sites - Shanghai East HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06963814) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [HC Biopharma Inc.](https://trialight.com/data/company/hc-biopharma-inc-806391e0-f8e8-4c07-bd8e-269e7bd5bc61.md) ### Conditions (1) - [Metastatic malignant neoplasm](https://trialight.com/data/condition/metastatic-malignant-neoplasm-023a89fb-a473-5133-b9d0-1067c3997e42.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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