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A Study of DM002 in Patients With Advanced Solid Tumors

NCT06751329 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-01-15

No results posted yet for this study

Summary

The goal of study：

The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.

In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.

The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.

In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.

The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.

Participants will:

Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.

Conditions

  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Endometrial Neoplasms
  • Colorectal Neoplasms
  • Solid Carcinoma

Interventions

DRUG

DM002

An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W

Sponsors & Collaborators

  • Xadcera Biopharmaceutical (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2027-10-08
Completion
2028-04-18
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06751329 on ClinicalTrials.gov