Clinical trial · Interventional
A Study of HC006 in Subjects With Advanced Solid Tumors
A Phase I, Open-label, Dose-Escalation and Dose-expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of HC006 in Advanced Solid Tumor Subjects
NCT06304571CI-TRIAL-00089349recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HC006 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HC006 Dose Escalation
- interventionNames
- Drug: HC006
- type
- EXPERIMENTAL
- label
- HC006 Dose Expansion
- interventionNames
- Drug: HC006
Primary outcomes (4)
- measure
- Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol
- timeFrame
- up to 24 months
- description
- Incidence of Dose Limiting Toxicities(DLTs)
- measure
- Number of participants with adverse events(AEs) as assessed by CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Other protocol defined exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.