Cancer study: AGX101
Official title A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06440005
What this study is testing
What is AGX101?
AGX101 is an investigational antibody‑drug conjugate being studied as a potential treatment for advanced solid cancers. It is designed to use an antibody to deliver a cell‑killing drug directly to tumor cells.
Also referred to as ADC.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe AGX101 is and how the body reacts to different doses in people with advanced solid tumors.
- Who it's for
- Adults who have advanced or metastatic solid cancers such as breast, prostate, colorectal, pancreatic, liver, or angiosarcoma.
- What's involved
- Participants receive AGX101 by IV infusion every 3, 6, or 9 weeks and may keep getting it until the cancer grows, side effects become too severe, or they choose to stop. They will have regular clinic visits and safety checks.
- Time commitment
- The trial lasts until disease progression or withdrawal, with follow‑up visits and two safety phone calls up to 90 days after the last dose.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Have an ECOG performance status of 0 to 1
You likely can't join if
- Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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
- Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Sarasota, Florida, United States
- St Louis, Missouri, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Sarasota, Florida, United States; St Louis, Missouri, United States; Nashville, Tennessee, United States; Houston, Texas, United States; San Antonio, Texas, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.