A Study of DXC018 in Patients With Advanced Solid Tumors

NCT07849218 | Not Yet Recruiting Phase 1

• 1 other identifier: DXC018-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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 DXC018 in participants with Advanced Solid Tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

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

  28 days

• Maximum tolerated dose

  After first infusion of study drug, through study with an average completion of 2 years

• Recommended Phase II dose

  After first infusion of study drug, through study with an average completion of 2 years

• Number of participants with adverse events (AEs)

  After first infusion of study drug, through study with an average completion of 2 years

Secondary Outcomes (14)

• Maximum observed serum or plasma concentration (Cmax)

  After first infusion of study drug, through study with an average completion of 2 years

• Anti-drug antibodies (ADA)

  After first infusion of study drug, through study with an average completion of 2 years

• 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 2 years

• Progression Free Survival (PFS)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Measurement of disease control rate (DCR)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Study Arms (1)

DXC018

EXPERIMENTAL

Drug: DXC018

Interventions

DXC018 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.

DXC018

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent form and comply with the protocol requirements.
• Male or female, age ≥18 years old and ≤75 years old.
• Participants with advanced malignancy confirmed by histology or cytology.
• Participants with locally advanced or metastatic solid tumors that cannot be surgically removed who have experienced disease progression after standard therapy, or are currently ineligible for standard therapy, or in lack of standard treatment. (Standard therapy is defined as per domestic consensus guidelines \[where applicable\] or treatment aligned with current domestic medical practice).
• At least one measurable lesion as defined by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy ≥ 3 months.
• Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 as defined by NCI-CTCAE v5.0 (except alopecia or vitiligo). Participants with grade 2 toxicities per NCI-CTCAE v5.0 may be enrolled with no safety risks judged by the investigators (e.g., Grade 2 peripheral neuropathy).
• Adequate organ function as defined by the following laboratory values:
• Hematological:
• Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (No use of G-CSF or granulocyte-/white blood cell-boosting drugs within 7 days prior to the screening lab test).
• Platelet count ≥ 90 × 10⁹/L (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test).
• Hemoglobin (HGB) ≥ 90 g/L (No red blood cell (RBC) or whole blood transfusion or hemoglobin-boosting drugs within 7 days prior to the screening lab test).
• Hepatic:
• Total Bilirubin (TBIL) ≤ 1.5 × ULN (Upper Limit of Normal); except for participants with congenital bilirubinemia, e.g., Gilbert's syndrome (TBIL ≤ 3.0 × ULN).

You may not qualify if:

• Participants with primary malignancies in other organs currently. Participants may be enrolled in the following scenarios: participants with healed basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in situ of the breast.Or participants with other malignancies achieving over 5-year disease-free survival.
• Serum pregnancy test: Positive or breastfeeding woman.
• Received systemic anti-tumor therapy or investigational drug without washout. Received major surgeries treatment within 28 days prior to the first dose. Received local radiotherapy within 14 days prior to the first dose.
• History of solid organ transplantation.
• Participants with primary central nervous system (CNS) tumors or CNS metastases. With the following exceptions: asymptomatic and stable brain metastases, or participants who have not received steroid or other treatments for brain metastases ≥ 28 days.
• History of grade 3 or higher allergic reactions to trastuzumab injection, pertuzumab injection, or similar biological products. History of allergy to any component or excipient of DXC018.
• Evidence of severe or uncontrollable heart diseases that require treatments, including any of the following: Class III or IV heart failure defined by the New York Heart Association (NYHA) functional classification system. Uncontrollable unstable angina. History of myocardial infarction within 6 months prior to screening. Evidence of clinically significant arrhythmias except atrial fibrillation and paroxysmal supraventricular tachycardia.
• QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula \[QTcF\]).
• Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Received strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose.
• Participants with interstitial lung disease or history of non-infectious pneumonia who have received steroid treatments currently (except mild illness judged by investigators, including mild interstitial lung disease, stable radiation pneumonitis, or chronic pneumonitis) Other conditions which result in severe pulmonary function impairement.
• Presence of severe unhealed wounds, ulcers, or fractures.
• Participants who have an active infection requiring medication within 2 weeks before the first dose of the study drug.
• Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or ≥ 2000 copies/mL; active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).
• HIV serology: positive; active syphilis (participants with only a positive syphilis antibody test may be enrolled).

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (4)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

Jinan Central Hospital

Jinan, Shandong, 250000, China

Location

FUDAN University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201321, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Pengyu Shi

CONTACT

+86-0571-56050590; Shipengyu@dacbiotech.com

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: September 22, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 18, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)