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

NCT06926283 | Recruiting Phase 1

• 1 other identifier: DXC008-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ewing Sarcoma; Prostate Cancer; Other Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

  Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.

  28 days

• Number of participants with adverse events (AEs).

  The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.

  After first infusion of study drug, Through study completion an average of 1 year.

Secondary Outcomes (5)

• Maximum observed serum or plasma concentration (Cmax).

  Through study completion an average of 1 year.

• Maximum serum drug time (Tmax).

  Through study completion an average of 1 year.

• Apparent volume of distribution(Vd).

  Through study completion an average of 1 year.

• Measurement of objective response rate (ORR) per RECIST 1.1.

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

• ORR per Prostate Cancer Working Group 3 (PCWG3).

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Study Arms (1)

DXC008

EXPERIMENTAL

Drug: DXC008

Interventions

DXC008 DRUG

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.

DXC008

Eligibility Criteria

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

You may qualify if:

• Those who voluntarily sign the ICF and follow the protocol requirements.
• Male or female.
• Age: ≥ 18 years and ≤ 75 years.
• Expected life expectancy ≥ 6 months.
• ECOG performance status score: 0-2.
• Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.
• Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng/dL (≤1.73 nmol/L).
• Cohort 1: at least one measurable lesion as defined by RECIST v1.1. Cohort 2: at least one metastatic lesion on CT/MRI, or bone scan imaging at baseline. Patients are assigned to the appropriate cohort as assessed by the investigator, the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously, it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.
• Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by investigator judgment (eg, Grade 2 peripheral neurotoxicity).
• Organ function of the subjects must meet the following requirements:
• Hematology:
• ANC ≥ 1.5 × 10\^9/L (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests).
• Platelet count ≥100×10\^9/L (platelet transfusion is not allowed within 7 days before the screening laboratory tests).
• HGB ≥ 90 g/L (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).
• Liver function:

You may not qualify if:

• Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \> 10 mg/day for \> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).
• Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.
• Have received monoclonal antibody treatment within 30 days prior to the first dose.
• History of solid organ transplantation.
• Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).
• Presence of meningeal or brain metastases.
• Evidence of cardiovascular risk, including any of the following:
• QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]).
• Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.
• Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.
• Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.
• Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
• Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).
• History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.
• Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Study Officials

• Zhisong He

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhisong He, Doctor

CONTACT

+86-010-83572600; wyj7074@sohu.com

Zhisong He

CONTACT

+86-010-83572600

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2025-04

Locations

CN (3)