RecruitingPhase 1NCT06926283

A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors

A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)


Sponsor

Hangzhou DAC Biotechnology Co., Ltd.

Enrollment

110 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing DXC008 — a new drug — in patients with prostate cancer that has spread and is no longer responding to hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC), as well as other solid tumours that have failed standard treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have a solid tumour (including mCRPC) that has not responded to standard treatments - Your testosterone level is very low (≤50 ng/dL — indicating hormone therapy is working to suppress testosterone) - Your expected survival is at least 6 months and your general health is adequate (ECOG 0–2) - You have measurable disease on scans or at least one metastatic lesion visible on imaging **You may NOT be eligible if...** - Your testosterone level is above the threshold required - You have poor organ function or a serious concurrent illness - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDXC008

Cohort A: Once every 2 weeks (Q2W) with a cycle length of 14 days. Cohort B: Once every 3 weeks (Q3W) with a cycle length of 21 days.


Locations(3)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06926283


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