CancerPhase 1NCT06440005
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
A Phase 1 study testing AGX101 in people with Cancer and Advanced Cancer, run by Angiex, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Cancer, Locally Advanced Carcinoma
- What is being tested?
- AGX101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Jul 2024to 6 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Blake Patterson, 703-783-4505
Alexander Spira, MD
- Recruiting
UT MD Anderson
Houston, Texas, 77030
Ann Mosley, CCRP, 713 792 2682, AEMosley@mdanderson.org
Michael Nakazawa
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Diana Hanna, MD
- Recruiting
Sarah Cannon Research Center
Nashville, Tennessee, 37203
Rebecca Beaman, becky.beaman@scri.com
Meredith P Pelster, MD
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Amanda Betancourt, abetancourt@nextoncology.com
Ismael Rodriguez Rivera, MD
- Recruiting
Florida Cancer Specialist
Sarasota, Florida, 34232
Nancy Olsen, 941-377-9993 ext. 1 21655, nolsen@flcancer.com
Judy Wang, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Sara Mitchum, 314-273-8602, saram@wustl.edu
Saiama Waqar, MD
About this study
Official title: 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
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.
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor, Breast Cancer, Prostate Cancer
- Being tested
- AGX101
- Keywords
- ADC, Antibody Drug Conjugate, AGX101
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGX101Drug
Also called ADC
Antibody Drug Conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma. Receives: Drug: AGX101 |
| Dose Expansion Phase | Experimental | AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type. Receives: Drug: AGX101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable maximum tolerated dose for participants
Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized
Measured: 21 days following the first dose of AGX101 (Day 1 through Day 21)
Number of participants with adverse events
Evaluation of the incidence, severity, and duration of adverse events
Measured: Screening through end of treatment, approximately 6 months and up to 3 years
Secondary outcomes (10)
Terminal elimination half life (PK)
Determination of the terminal elimination half-life (t½)
Measured: 22 days following the first dose of AGX101 (Day 1 through Day 22)
AUC (PK)
Determination of the AUC in 1 dosing interval
Measured: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Cmax (PK)
Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state
Measured: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Number of Participants with Antidrug Antibodies (ADA) to AGX101
Incidence and titers of ADA will be measured
Measured: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Determination the objective response rate (ORR)
Measured: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Response (DoR) Assessed by Investigator
Determination of the duration of response (DoR)
Measured: Approximately 6 months and up to 3 years
Efficacy as measured by Disease Control Rate (DCR)
Determination of the disease control rate (DCR)
Measured: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator
Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).
Measured: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Treatment
Measured: Approximately 6 months and up to 3 years
Overall Survival
Measured: Approximately 6 months and up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start22 Jul 2024
- Primary completion6 Mar 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Study director, Medical Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440005
- Sponsor's protocol ID
- AGX101-001
- Status last verified
- Sep 2026
- First submitted
- 26 May 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06440005
- Acronym / sponsor ID
- AGX101-001
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor, Breast Cancer, Prostate Cancer
- Keywords
- ADC, Antibody Drug Conjugate, AGX101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Angiex, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 6 Mar 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Drug: AGX101AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma. |
| Dose Expansion Phase | Experimental | Drug: AGX101AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGX101Also: ADCAntibody Drug Conjugate | Drug | Dose Escalation Phase, Dose Expansion Phase |
Primary outcome
Acceptable maximum tolerated dose for participants
Time frame: 21 days following the first dose of AGX101 (Day 1 through Day 21)
Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized
Number of participants with adverse events
Time frame: Screening through end of treatment, approximately 6 months and up to 3 years
Evaluation of the incidence, severity, and duration of adverse events
10 secondary outcomes
Terminal elimination half life (PK)
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
AUC (PK)
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Cmax (PK)
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Number of Participants with Antidrug Antibodies (ADA) to AGX101
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Response (DoR) Assessed by Investigator
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Disease Control Rate (DCR)
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Treatment
Time frame: Approximately 6 months and up to 3 years
Overall Survival
Time frame: Approximately 6 months and up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glen Weiss, MD study director
Medical Lead
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGX101 in people with Cancer and Advanced Cancer, run by Angiex, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glen Weiss, MD (857-203-7808, trials@angiex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptable maximum tolerated dose for participants (time frame: 21 days following the first dose of AGX101 (Day 1 through Day 21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.