A Study of DM002 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Study ID
NCT06751329
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Jan 2026
Primary completion
Oct 8, 2027
Completion
Apr 18, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    1.0 mg/kg
  • Experimental: Dose Level 2
    ≤2.0 mg/kg
  • Experimental: Dose Level 3
    ≤3.0 mg/kg,
  • Experimental: Dose Level 4
    ≤4.5 mg/kg
  • Experimental: Dose Level 5
    ≤6.0 mg/kg
  • Experimental: Dose Level 6
    ≤7.5 mg/kg

Primary Outcome Measure

Dose-limiting Toxicities (DLTs) of DM002 [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73190
Kathleen Moore, Doctor
[email protected]
(405) 271-8778
The University of Texas, MD Anderson Cancer CenterHoustonTexas77030
Siqing Fu
[email protected]
832-817-9581

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University of Oklahoma Health Sciences Center· Oklahoma City, OKThe University of Texas, MD Anderson Cancer Center· Houston, TX

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