Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06562192
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-NNS309 — DRUG
    Radioligand imaging agent
  • [177Lu]Lu-NNS309 — DRUG
    Radioligand therapy

Study Details

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Key Dates

Start date
Oct 15, 2024
Status verified
Apr 2026
Primary completion
Jan 15, 2031
Completion
Jan 16, 2031

Study Design

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

Arms

  • Experimental: Arm 1
    Patients will receive \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309

Primary Outcome Measure

Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 [ Time Frame: From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Uni of Alabama at BirminghamBirminghamAlabama35249
Sebastian Eady
[email protected]
Jonathan McConathy (PRINCIPAL_INVESTIGATOR)
University of California LALos AngelesCalifornia90095
Jonathan W Goldman (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterPalo AltoCalifornia94304
Maria Isabel Leonio
[email protected]
Farshad Moradi (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Alberta Lalljie
[email protected]
904-953-7648
Ephraim Parent (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Jonathan Robert Kim
[email protected]
Shadi Abdar Esfahani (PRINCIPAL_INVESTIGATOR)
BAMF HealthGrand RapidsMichigan49503
Brandon Mancini (PRINCIPAL_INVESTIGATOR)
BAMF HealthGrand RapidsMichigan49503
Brandon Mancini (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Lucas Hamann
[email protected]
507-538-2155
Andrea Wahner Hendrickson (PRINCIPAL_INVESTIGATOR)
Uni Of TX MD Anderson Cancer CntrHoustonTexas77030
Denisse Harkins
[email protected]
713-792-2921
Jordi Rodon (PRINCIPAL_INVESTIGATOR)
University Of WashingtonSeattleWashington98109
Heather White
[email protected]
Amir Iravani (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Colorectal cancerLung cancerPancreatic cancerBreast cancer
By specialty
OncologyGI oncologyLung oncologyLung diseaseBreast oncologyWomen's health
By research site
Uni of Alabama at Birmingham· Birmingham, ALUniversity of California LA· Los Angeles, CAStanford University Medical Center· Palo Alto, CAMayo Clinic Jacksonville· Jacksonville, FLMassachusetts General Hospital· Boston, MABAMF Health· Grand Rapids, MI

Related Studies