A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors

August 4, 2026 updated by: Immedica Pharma AB

A Phase 1 Multiple Dose, Dose Escalation Trial of AEB1102 (Co-Arg1-PEG) in Patients With Advanced Solid Tumors

A first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this phase 1 multiple dose, dose escalation study utilizing a classic 3+3 design. Sequential cohorts of patients will receive AEB1102 IV weekly at one of a series of increasing dose levels. Dose escalation will be dependent on the frequency of specific dose-limiting toxicities in the prior cohort of patients. The study will determine the maximum tolerated dose (MTD) of AEB1102, evaluate the safety profile of the compound, assess the pharmacokinetic profile of AEB1102, determine the effect of AEB1102 on blood arginine levels and evaluate the anti-tumor activity of AEB1102.

Following the determination of the MTD, additional cohorts of patients with uveal, cutaneous melanoma and small cell lung cancer will be enrolled and treated with AEB1102 at the MTD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85258
        • Pinnacle Research
    • California
      • Los Angeles, California, United States, 90024
        • UCLA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Orange City, Florida, United States, 32763
        • Research Center: Mid Florida Hematology/Oncology Centers
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General
      • Boston, Massachusetts, United States, 02114
        • Dana Farber
    • Missouri
      • St Louis, Missouri, United States, 93110
        • Washington University
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390-8852
        • UTSW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For patients participating in any part of the trial:

  • has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment
  • has adequate organ function: Hgb ≥9 g/dL; absolute neutrophil count (ANC) ≥ 1.5x109/L; plt ≥ 100,000/μL; AST and ALT < 2.5x ULN (< 5x ULN in patients with liver metastases); total bilirubin < 2.0 mg/dL; serum creatinine ≤ 1.5x ULN
  • ECOG performance score 0-2

For patients participating in any expansion group:

  • has measurable disease based on RECIST 1.1 as determined by the treating investigator. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • willing to consent for biopsy is strongly recommended but not mandatory
  • recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v 4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant and/or stable on supportive therapy.

For patients participating in specific expansion groups:

Cutaneous Melanoma:

  • unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma
  • relapsed or progressive disease after or unable to tolerate at least one prior systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4)
  • in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at least one prior systemic anticancer regimen for metastic disease involving a BRAF inhibitor

Uveal Melanoma:

  • uveal melanoma at metastic stage

Small Cell Lung Cancer:

  • extensive disease previously treated with, or inability to tolerate, platinum-based chemotherapy

Exclusion Criteria:

  • has primary CNS malignancy
  • history of untreated brain mets or leptomeningeal disease or spinal cord compression
  • effects of prior anticancer therapy recovered to grade < 2
  • known HIV
  • active infection
  • major surgery within 2 weeks
  • history of another malignancy within 2 years prior

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AEB1102 Dose Escalation Cohort 1
3 patients dosed at 0.01 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 2
4 patients dosed at 0.02 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 3
4 patients dosed at 0.04 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 4
4 patients dosed at 0.08 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 5
3 patients dosed at 0.12 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 6
4 patients dosed at 0.18 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 7
5 patients dosed at 0.27 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 8
7 patients dosed at 0.40 mg/kg until MTD determined
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Dose Escalation Cohort 9
7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Expansion Cutaneous
11 Cutaneous Melanoma patients dosed at 0.33 mg/kg
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Expansion Uveal
12 Uveal Melanoma patients dosed at 0.33 mg/kg
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102
Experimental: AEB1102 Expansion SCLC
13 SCLC patients dosed at 0.33 mg/kg
Drug: Co-ArgI-PEG
Administered IV
Other Names:
  • AEB1102

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maximum tolerated dose
Time Frame: 4 weeks
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
safety profile (changes in physical exam, laboratory measures, reported adverse events)
Time Frame: 4 weeks +
changes in physical exam, laboratory measures, reported adverse events
4 weeks +

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immedica Pharma AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aeglea Biotherapeutics (Study sponsor)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mattias Rudebeck, PhD MSc BMedSc, Immedica Pharma AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAEB1102-100B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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