A Study of HC006 in Subjects With Advanced Solid Tumors

NCT06304571 | Recruiting Phase 1 DMC

• 1 other identifier: HC006-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol

  Incidence of Dose Limiting Toxicities(DLTs)

  up to 24 months

• Number of participants with adverse events(AEs) as assessed by CTCAE v5.0

  Incidence of adverse events(AEs)

  up to 24 months

• Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0

  Incidence of Serious adverse events(SAEs)

  up to 24 months

• Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0

  Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0

  up to 24 months

Secondary Outcomes (11)

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

  up to 24 months

• PK Parameter:Time to reach Cmax (Tmax)

  up to 24 months

• PK Parameter:Area Under the Concentration-time Curve (AUC)

  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 Dose Escalation

EXPERIMENTAL

Drug: HC006

HC006 Dose Expansion

EXPERIMENTAL

Drug: HC006

Interventions

HC006 DRUG

Specified dose on specified days

HC006 Dose Escalation; HC006 Dose Expansion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Central Study Contacts

langxi Zhang, PhD

CONTACT

00-86-021-50433368; langxi.zhang@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: March 5, 2024
• First Posted: March 12, 2024
• Study Start: February 27, 2024
• Primary Completion: March 15, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)