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Recruiting Phase 1

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

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About this study

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.

Condition
Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor, Breast Cancer, Prostate Cancer, Colorectal Cancer, Pancreatic Cancer, Liver Cancer, Angiosarcoma, Solid Tumor
Tested
AGX101
Sponsor
Angiex, Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 18 years
  • Study condition: Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor, Breast Cancer, Prostate Cancer, Colorectal Cancer, Pancreatic Cancer, Liver Cancer, Angiosarcoma, Solid Tumor
  • 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 16

  • 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

Where

7 sites, 7 recruiting

NEXT Oncology

Fairfax, Virginia, United States

Recruiting

UT MD Anderson

Houston, Texas, United States

Recruiting

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Recruiting

Sarah Cannon Research Center

Nashville, Tennessee, United States

Recruiting

NEXT Oncology

San Antonio, Texas, United States

Recruiting

Florida Cancer Specialist

Sarasota, Florida, United States

Recruiting

and 1 more site on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.