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

NCT06963814 | Recruiting Phase 1 DMC

• 1 other identifier: BT-HC006-102
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose Limiting Toxicities(DLTs)

  Incidence of Dose Limiting Toxicities(DLTs)

  up to 24 months

Secondary Outcomes (3)

• Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)

  up to 24 months

• Immunogenicity

  up to 24 months

• Objective Response Rate (ORR) per RECIST 1.1

  up to 24 months

Study Arms (2)

HC006+ keytruda Dose Escalation

EXPERIMENTAL

Drug: HC006; Drug: KEYTRUDA ®( Pembrolizumab)

HC006 +keytruda Dose Expansion

EXPERIMENTAL

Drug: HC006; Drug: KEYTRUDA ®( Pembrolizumab)

Interventions

HC006 DRUG

Specified dose on specified days

HC006 +keytruda Dose Expansion; HC006+ keytruda Dose Escalation

KEYTRUDA ®( Pembrolizumab) DRUG

Specified dose on specified days

HC006 +keytruda Dose Expansion; HC006+ keytruda Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand this trial and voluntarily sign the informed consent form;
• Advanced solid tumors diagnosed by histology or cytopathology;
• 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;
• At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
• Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
• The expected survival time is more than 3 months;
• Adequate organ and bone marrow function
• 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).

You may not qualify if:

• Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
• Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
• Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
• Conditions may significantly affect the autoimmune status;
• Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
• Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;
• 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;

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Central Study Contacts

Ke Yao, master

CONTACT

028-85142721; ke.yao@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CN (1)