A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 90 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests AGX101 in people with advanced cancers that form solid tumors. AGX101 links an antibody to a drug and is given through a vein. Researchers will test different doses to learn about its safety, side effects, and early signs that it may work.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a solid tumor confirmed by a tissue test that cannot be removed by surgery, has grown nearby, or has spread.
- Standard treatments have failed or the cancer has returned, or standard treatment is unavailable, unsuitable, or refused after understanding the options.
- Allow use of stored tumor tissue, unless another plan is discussed with the study sponsor.
- Wait the required time after your last cancer treatment. The wait depends on the drug and may be 2 weeks, 3 weeks, 6 weeks, or longer.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Have organs that work well enough for the study.
- Have a heart scan showing that the heart pumps out at least 50% of the blood in its main pumping chamber with each beat.
- Use highly effective birth control throughout the study, for both men and women.
Who can't join
- Have colon or rectal cancer with the original tumor still in place, or lung cancer that is mainly squamous cell cancer, unless the sponsor approves.
- Have unstable tumors in the brain or spinal cord, or unstable cancer spread to the brain. Stable spread or spread without symptoms may be allowed.
- Still have more than mild side effects from past treatment, unless back to your usual health level or an exception is approved; or have significant eye problems.
- Have blood vessel swelling that needed whole-body treatment in the past 2 years; recent bleeding from swollen veins, untreated bleeding veins, or high bleeding risk; or serious heart or blood vessel disease.
- Have an uncontrolled or life-threatening illness, certain active infections, or an infection needing antibiotics that treat the whole body.
- Had major surgery within 3 weeks, have not healed well after surgery, or had radiation within 2 weeks; or have another potentially life-threatening cancer that needed whole-body treatment within 3 years or would affect study results.
- Are receiving another cancer treatment, except certain radiation for symptom relief or hormone-blocking treatment; or take certain strong medicines affecting AGX101 processing and cannot switch.
- Have a positive pregnancy test, are breastfeeding, or plan to become pregnant or father a child during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (7)
CA
- USC/Norris Comprehensive Cancer Center · Los Angeles, CA 90033Diana Hanna, MD · Principal investigatorMore trials in Los Angeles
FL
- Florida Cancer Specialist · Sarasota, FL 34232Nancy Olsen · Study contact · 941-377-9993 ext. 1 21655 · nolsen@flcancer.comJudy Wang, MD · Principal investigatorMore trials in Sarasota
MO
- Washington University School of Medicine · St Louis, MO 63110Sara Mitchum · Study contact · 314-273-8602 · saram@wustl.eduSaiama Waqar, MD · Principal investigatorMore trials in St Louis
TN
- Sarah Cannon Research Center · Nashville, TN 37203Rebecca Beaman · Study contact · becky.beaman@scri.comMeredith P Pelster, MD · Principal investigatorMore trials in Nashville
TX
- UT MD Anderson · Houston, TX 77030Ann Mosley, CCRP · Study contact · 713 792 2682 · AEMosley@mdanderson.orgMichael Nakazawa · Principal investigatorMore trials in Houston
- NEXT Oncology · San Antonio, TX 78229Amanda Betancourt · Study contact · abetancourt@nextoncology.comIsmael Rodriguez Rivera, MD · Principal investigatorMore trials in San Antonio
VA
- NEXT Oncology · Fairfax, VA 22031Blake Patterson · Study contact · 703-783-4505Alexander Spira, MD · Principal investigatorMore trials in Fairfax