A Study of DM005 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Doma Biopharmaceutical（Suzhou）Co., Ltd.
Study ID
NCT06515990
Phase
PHASE1
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Solid Carcinoma
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • DM005 — DRUG
    An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W.

Study Details

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.

Key Dates

Start date
Oct 31, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Dose Level 1
    0.5mg/kg
  • Experimental: Dose Level 2
    ≤1 mg/kg
  • Experimental: Dose Level 3
    ≤2 mg/kg
  • Experimental: Dose Level 4
    ≤4 mg/kg
  • Experimental: Dose Level 5
    ≤6 mg/kg
  • Experimental: Dose Level 6
    ≤8 mg/kg

Primary Outcome Measure

Dose-limiting Toxicities (DLTs) of DM005 [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Henry Ford Cancer InstituteDetroitMichigan48202
Shirish Gadgeel
Sarah Cannon Research Institute at Mary CrowleyDallasTexas75251
Reva Schneider
NEXT Oncology VirginiaFairfaxVirginia22031
ALEXANDER SPIRA

Find similar trials in Detroit, MI

By research site
Henry Ford Cancer Institute· Detroit, MISarah Cannon Research Institute at Mary Crowley· Dallas, TXNEXT Oncology Virginia· Fairfax, VA

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