No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Angiex, Inc. · Industry
Who this trial is looking for
This trial is looking for people with advanced solid tumors that cannot be removed by surgery. Participants will receive the drug AGX101 through an IV and will attend follow-up visits after treatment.
Are You a Good Fit for This Trial?
Rules you outActive hepatitis B or CMajor cardiovascular diseaseSignificant CNS issues
You may be able to join if
I have been diagnosed with an advanced solid tumor.
I have received all standard cancer treatments and they didn’t work.
I can provide tissue samples for study.
At least 2 weeks have passed since my last chemotherapy.
I have an ECOG performance status of 0 to 1.
My organs are functioning well.
My heart function is adequate.
I will use effective contraception during the study.
You may not be able to join if
I have colorectal cancer that has not been treated.
I have unstable CNS tumors or active brain metastasis.
I have not fully recovered from side effects of previous treatments.
I had significant eye problems.
I have had certain bleeding issues in the last 6 months.
I have ongoing infections needing antibiotics.
I am pregnant or breastfeeding.
I have had major surgery in the past 3 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, 6 or 9 weeks. Participants may continue study treatment until disease progressi…
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, 6 or 9 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.
Trial Locations
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City
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Status
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,…
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 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 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
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