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Cancer Vaccine

DM001 for Cancer

Phase 1
Recruiting
Research Sponsored by Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
4. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Subjects must be ≥18 years of age at the time of signing the informed consent form.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety, effectiveness, and tolerability of an experimental drug called DM001 for patients with advanced solid tumors. Participants will have up to 17 visits over the course of the study

Who is the study for?
This trial is for adults over 18 with certain advanced solid tumors, including breast cancer and non-small cell lung cancer (NSCLC), who have not responded to standard treatments or can't receive them. Participants must understand the study and agree to join, have a life expectancy of at least 3 months, and be able to perform daily activities with minimal assistance (ECOG status of 0 or 1).
What is being tested?
DM001, an experimental drug for treating advanced solid tumors, is being tested for safety and effectiveness. The treatment period consists of cycles lasting three weeks each. Patients will visit the clinic multiple times during these cycles for assessments.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions seen in cancer therapies such as nausea, fatigue, pain at injection sites, allergic reactions or more serious complications depending on how DM001 works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or have some restrictions but can still care for myself.
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I am 18 years old or older.
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My cancer has worsened despite standard treatments or I cannot tolerate them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting Toxicities (DLTs) of DM001
Maximum tolerated dose (MTD) for DM001
Secondary study objectives
Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL)
Maximum (peak) plasma concentration (Cmax, ng/mL)
Objective response rate (ORR)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DM001 administrated to subjects with advanced or metastatic solid tumorsExperimental Treatment1 Intervention
An IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W

Find a Location

Who is running the clinical trial?

Xadcera Biopharmaceutical (Suzhou) Co., Ltd.Lead Sponsor
Zhaorong Chen, CMOStudy ChairXadcera Biopharmaceutical (Suzhou) Co., Ltd.
~85 spots leftby Aug 2026
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