A Study of DM001 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Study ID
NCT06475937
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • DM001 — DRUG
    Subjects may continue to receive DM001 (with an increased dose that has been assessed as safe in the dose-escalation period) once every 3 weeks (Q3W) for a total of 6 cycles at the discretion of the investigators, until unacceptable toxicity, progressive disease (PD), or withdrawal of consent.

Study Details

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.

Key Dates

Start date
Oct 24, 2024
Status verified
Feb 2025
Primary completion
Aug 13, 2026
Completion
Feb 13, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DM001 administrated to subjects with advanced or metastatic solid tumors
    An IV infusion of DM001 will be administrated approximately 30-60 min on Day 1 once Q3W

Primary Outcome Measure

Dose-limiting Toxicities (DLTs) of DM001 [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute (SCRI)NashvilleTennessee37203
Aaron Ferry
[email protected]
615-766-3479
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Becky Norris
[email protected]
713-563-4646

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