a study to evaluate safety, tolerability and preliminary activity of agx101 in participants with advanced solid tumors

Conditions: Cancer; Advanced Cancer; Locally Advanced Carcinoma; Metastatic Solid Tumor; Breast Cancer; Prostate Cancer; Colorectal Cancer; Pancreatic Cancer; Liver Cancer; Angiosarcoma; Solid Tumor

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, 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.


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 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

Keywords: adc antibody drug conjugate agx101