First in Human Study of TUB-030 in Patients With Advanced Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Tubulis GmbH
Study ID
NCT06657222
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • CRC
  • HNSCC
  • NSCLC
  • SCLC
  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

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

Interventions

  • TUB-030 — DRUG
    A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Study Details

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

Key Dates

Start date
Dec 13, 2024
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: dose escalation
    Drug TUB-030, administered by intravenous (IV) infusion
  • Experimental: Phase 2: dose optimization in NSCLC and HNSCC
    Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion

Primary Outcome Measure

Determination of MTD [ Time Frame: From enrollment until 30 days after last study drug ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63130-
Mount SinaiNew YorkNew York11766-
Cleveland ClinicClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
NEXT Oncology AustinAustinTexas78758-
NEXT Oncology - DallasIrvingTexas75039-
NEXT Oncology - San AntonioSan AntonioTexas78229-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in New Haven, CT

By condition
Head and neck cancerLung cancer
By specialty
OncologyENTLung oncologyLung disease
By research site
Yale Cancer Center· New Haven, CTUniversity of Miami· Miami, FLDana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNWashington University· St Louis, MOMount Sinai· New York, NY

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