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Study of DM002 for Advanced Solid Tumors

This study is testing a new treatment called DM002 for people with advanced solid tumors, including ovarian, prostate, endometrial, and colorectal cancers. DM002 is given as an intravenous (IV) infusion every three weeks. The study has two parts: the first part will test different doses of DM002 to find a safe and effective amount, and the second part will further explore the best dose. The main goals are to understand the side effects of DM002 and to determine the highest safe dose. You may be able to join if you are at least 18 years old and have an ECOG performance status of 0, 1, or 2 (a measure of your general well-being). The current recruitment status is unclear.

Study design
This study is an interventional study with an unclear phase, aiming to enroll 280 participants. It has two parts: a dose escalation phase followed by a dose expansion phase.
What's involved
You would receive DM002 as an IV infusion approximately 30-60 minutes on Day 1, once every three weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which include measuring dose-limiting toxicities and the maximum tolerated dose, are measured at 12 months.

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NCT06751329

A Study of DM002 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
~280 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:DM002

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting Toxicities (DLTs) of DM002
Measured over 12 months
+1 more outcome measured

Conditions

Ovarian Neoplasms
Prostatic Neoplasms
Endometrial Neoplasms
Colorectal Neoplasms
Solid Carcinoma
Pancreatic Cancer

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Colorectal CarcinomaEndometrial CarcinomaMalignant Ovarian NeoplasmProstate CarcinomaSolid Neoplasm

Where it's being run

7 sites across 6 states
New South Wales2
California1
North Carolina1
Oklahoma1
Texas1
South Australia1

Who to contact

Phu Lam
[email protected]
(415) 476-7931
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
Platelet count ≥100 × 10⁹/L;
Hemoglobin ≥9 g/dL;
Calculated creatinine clearance (CrCL) \>60 mL/min (Cockroft-Gault Equation);
Total bilirubin ≤ 1.5 x ULN;
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;
International normalized ratio (INR)\<2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time/INR within therapeutic range as deemed appropriate by the Investigator. 6. Has measurable disease based on RECIST version 1.1. 7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and/or HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.

What this trial measures

  • Dose-limiting Toxicities (DLTs) of DM00212 months

    Incidence of DLTs of DM002 will be determined. A dose-limiting toxicity (DLT) is defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicities.

  • Maximum tolerated dose (MTD) for DM00212 months

    The MTD of DM002 will be determined. The MTD is defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose.