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Trial Title:
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
NCT ID:
NCT06440005
Condition:
Cancer
Advanced Cancer
Locally Advanced Carcinoma
Metastatic Solid Tumor
Triple Negative Breast Cancer
Pancreas Cancer
Pancreatic Adenocarcinoma
Conditions: Official terms:
Breast Neoplasms
Adenocarcinoma
Triple Negative Breast Neoplasms
Pancreatic Neoplasms
Conditions: Keywords:
ADC
Antibody Drug Conjugate
AGX101
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied
for dose-escalation and expansion to determine the AGX101 RP2D.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AGX101
Description:
Antibody Drug Conjugate
Arm group label:
Dose Escalation Phase
Arm group label:
Dose Expansion Phase
Other name:
ADC
Summary:
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose
of this study is to learn about AGX101 effects and safety at various dose levels in an
all-comers advanced solid cancer patient population. AGX101will be administered
intravenously.
Dosing of AGX101 will be repeated once every 3 weeks. Participants may continue study
treatment until disease progression, unacceptable toxicity, or consent withdrawal.
Subjects will attend an end of treatment visit and will receive two safety follow-up
telephone contacts up to 90 days following the last dose of study drug.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.
- Refractory to or relapsed after all standard therapies known to provide proven
clinical benefit, unless the patient is not a candidate for standard treatment,
there is no standard treatment, or the patient refuses standard treatment after
expressing an understanding of all available therapies with proven clinical benefit
- Willing to authorize use of existing archival tissue, unless otherwise discussed
with Sponsor
- Time since the last dose of prior therapy to treat underlying malignancy (including
other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of
the most recent cycle of the previous regimen (with a minimum of 2 weeks for all,
except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy
(eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life
- Have an ECOG performance status of 0 to 1
- Have adequate organ function
- LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition
(MUGA) scan
- Highly effective contraception for both male and female patients throughout the
study
Exclusion Criteria:
- Colorectal cancer and non-small-cell lung cancer with predominant squamous histology
(ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed
and approved by Sponsor
- Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable
and/or asymptomatic CNS metastases allowed)
- Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies
(patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be
eligible after discussion with the Sponsor)
- Has an active vasculitis that has required systemic treatment in the past 2 years
prior to starting study treatment
- Significant (ie, ≥ Grade 2) ocular disturbances
- Variceal bleeding within 6 months prior to treatment, currently untreated or
incompletely treated varices with bleeding, or who otherwise are at a high risk of
bleeding
- Any other concurrent antineoplastic treatment except for allowed local radiation of
lesions for palliation (to be considered non-target lesions after treatment) and
hormone ablation
- Uncontrolled or life-threatening symptomatic concomitant disease, including known
symptomatic HIV positive with an AIDS defining opportunistic infection within the
last year, known symptomatic active hepatitis B or C, or known active tuberculosis
- Has undergone a major surgery within 3 weeks prior to starting study treatment or
has inadequate healing or recovery from complications of surgery prior to starting
study treatment
- Has received prior radiotherapy within 2 weeks prior to starting study treatment
- Has or had a potentially life-threatening second malignancy requiring systemic
treatment within the last 3 years, or which would impede evaluation of treatment
response
- Clinically significant cardiovascular disease
- Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to
another medication
- Has an active infection requiring concurrent systemic antibiotic therapy
- A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior
to treatment
- Is breastfeeding or expecting to conceive or father children within the projected
duration of the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Beaman
Email:
becky.beaman@scri.com
Investigator:
Last name:
Meredith P Pelster, MD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Betancourt
Email:
abetancourt@nextoncology.com
Investigator:
Last name:
Ismael Rodriguez Rivera, MD
Email:
Principal Investigator
Start date:
July 22, 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Angiex, Inc.
Agency class:
Industry
Source:
Angiex, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440005
