A Study of DXC016 in Patients With Advanced Solid Tumors.

A Phase I, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DXC016 in Participants With Advanced Solid Tumors.

The investigational product DXC016 is an antibody-drug conjugate (ADC) targeting c-Met. Preclinical studies have demonstrated definitive antitumor activity and a manageable safety profile. On this basis, this first-in-human trial will be conducted in participants with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of DXC016, with the aim of determining the recommended Phase II dose (RP2D) and identifying the population most likely to benefit, thereby informing subsequent clinical development.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Cohort A: DXC016 dose escalation; Drug: Cohort B: DXC016 dose expansion

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pengyu Shi; Phone Number: +086-0571-56050590; Email: Shipengyu@dacbiotech.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510050
      • Sun Yat-sen University Cancer Center
      • Contact: Ruihua Xu, MD (Doctor of Medicine); Phone Number: +086-020-87343468; Email: xurh@sysucc.org.cn
  • Guangxi
    • Nanning, Guangxi, China, 530200
      • Guangxi Medical University Cancer Hospital
      • Contact: Yongqiang Li, Master of Medicine; Phone Number: +086-0771-5331955; Email: lyq702702@126.com
  • Jiangxi
    • Nanchang, Jiangxi, China, 330052
      • The First Affiliated Hospital of Nanchang University
      • Contact: Yong Li, MD (Doctor of Medicine); Phone Number: +086-0791-8631933; Email: liyongcsco@qq.com
      • Contact: Pu Li, MD (Doctor of Medicine); Phone Number: +086-0791-8631933; Email: 13970998685@163.com
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Cancer Hospital
      • Contact: Hongxia Lu, Master of Medicine; Phone Number: +086-0351-4881611; Email: 53473139@qq.com
      • Contact: Wang Xin, MD (Doctor of Medicine); Phone Number: +086-0351-4881611; Email: WXCAMS@126.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
      • Contact: Ji Zhu, MD (Doctor of Medicine); Phone Number: +086-0571-88122222; Email: zhuji@zjcc.org.cn
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
      • Contact: Haizhou Lou, MD (Doctor of Medicine); Phone Number: +086-0571-86090073; Email: louhz09@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must be able to provide documented voluntary informed consent and be aged ≥ 18 years.
2. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer, gastric adenocarcinoma / gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer, hepatocellular carcinoma, cholangiocarcinoma, or other solid tumors, who have experienced disease progression during standard therapy, are intolerant of standard therapy, or have no standard therapy available.
3. Measurable disease defined by RECIST version 1.1.
4. ECOG 0-1.
5. Life expectancy ≥ 3 months.
6. Must have adequate organ function.
7. Female participants of childbearing potential (WOCBP) must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not donate ova or undergo oocyte retrieval for their own use. Male participants must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not cryopreserve or donate sperm.
8. Additional inclusion criteria for the dose expansion phase must be met, including requirements regarding tumor-type-specific disease history, number of prior lines of therapy, etc.
9. Able to provide a tumor tissue specimen.

Exclusion Criteria:

1. Has a history of any other malignancy.
2. Has active central nervous system (CNS) involvement.
3. Has uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion).
4. Has had an active autoimmune disease requiring systemic immunosuppressive therapy within 12 months prior to signing the informed consent form.
5. Has an active infection or medical condition requiring systemic antibiotic therapy within 7 days prior to the first dose of the study drug.
6. Known human immunodeficiency virus (HIV) infection.
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
8. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
9. Currently has active, non-infectious interstitial lung disease (ILD)/pneumonitis requiring systemic corticosteroid treatment, etc..
10. Toxicities related to prior antineoplastic therapy that have not resolved to ≤ Grade 1 or returned to baseline.
11. Known allergy, hypersensitivity, or intolerance to DXC016 or any of its excipients.
12. Has undergone major surgery within 30 days prior to the first dose of study treatment, or has not yet recovered from the surgery.
13. Inadequate washout period from prior therapy prior to the first dose of the study drug.
14. Prior treatment with c-Met-targeted therapies (including antibodies, ADCs, chimeric antigen receptor T-cell [CAR-T] therapy, and other agents), with the exception that prior treatment with c-Met-targeted tyrosine kinase inhibitors (TKIs) is permitted.
15. Any disease, medical condition, organ system dysfunction, or social situation that, in the opinion of the investigator, may interfere with the participant's ability to sign the informed consent form, adversely affect the participant's ability to cooperate and participate in the study, or compromise the interpretation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort B	Drug: Cohort B: DXC016 dose expansion; Subcutaneous (SC) administration (QW, Q2W or Q3W)
Experimental: Cohort A	Drug: Cohort A: DXC016 dose escalation; Subcutaneous (SC) administration (QW, Q2W or Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs)	Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0	From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment
Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)	To determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DXC016	Assess approximately 12 months
Recommended Doses for phase 2 (RP2D)	To determine the Recommended Doses for phase 2 (RP2D) of DXC016	from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first

Collaborators and Investigators

• Sponsor: Hangzhou DAC Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DXC016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No