Advanced CancersPhase 1NCT02561234
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
A Phase 1 study testing Co-ArgI-PEG in people with Advanced Cancers, run by Immedica Pharma AB at 11 sites in United States.
Trial summary
A first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Co-ArgI-PEG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Oct 2015to 28 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Colorado
Aurora, Colorado, 80045
Dana Farber
Boston, Massachusetts, 02114
Massachusetts General
Boston, Massachusetts, 02114
UTSW
Dallas, Texas, 75390-8852
UCLA
Los Angeles, California, 90024
Columbia University
New York, New York, 10032
Research Center: Mid Florida Hematology/Oncology Centers
Orange City, Florida, 32763
Pinnacle Research
Phoenix, Arizona, 85258
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Providence Cancer Center
Portland, Oregon, 97213
Washington University
St Louis, Missouri, 93110
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Co-ArgI-PEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-ArgI-PEGDrug
Also called AEB1102
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| AEB1102 Dose Escalation Cohort 1 | Experimental | 3 patients dosed at 0.01 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 2 | Experimental | 4 patients dosed at 0.02 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 3 | Experimental | 4 patients dosed at 0.04 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 4 | Experimental | 4 patients dosed at 0.08 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 5 | Experimental | 3 patients dosed at 0.12 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 6 | Experimental | 4 patients dosed at 0.18 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 7 | Experimental | 5 patients dosed at 0.27 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 8 | Experimental | 7 patients dosed at 0.40 mg/kg until MTD determined Receives: Drug: Co-ArgI-PEG |
| AEB1102 Dose Escalation Cohort 9 | Experimental | 7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg Receives: Drug: Co-ArgI-PEG |
| AEB1102 Expansion Cutaneous | Experimental | 11 Cutaneous Melanoma patients dosed at 0.33 mg/kg Receives: Drug: Co-ArgI-PEG |
| AEB1102 Expansion Uveal | Experimental | 12 Uveal Melanoma patients dosed at 0.33 mg/kg Receives: Drug: Co-ArgI-PEG |
| AEB1102 Expansion SCLC | Experimental | 13 SCLC patients dosed at 0.33 mg/kg Receives: Drug: Co-ArgI-PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
Measured: 4 weeks
Secondary outcomes (1)
safety profile (changes in physical exam, laboratory measures, reported adverse events)
changes in physical exam, laboratory measures, reported adverse events
Measured: 4 weeks +
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study start22 Oct 2015
- Primary completion28 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immedica Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aeglea Biotherapeutics
- Responsible party
- Sponsor
- Investigators
- Mattias Rudebeck, PhD MSc BMedSc, Study director, Immedica Pharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561234
- Sponsor's protocol ID
- CAEB1102-100B
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2015
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Dose, Dose Escalation Trial of AEB1102 (Co-Arg1-PEG) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02561234
- Acronym / sponsor ID
- CAEB1102-100B
- Conditions
- Advanced Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Immedica Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Aeglea Biotherapeutics
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 28 Sep 2015 (estimated)
- 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.
A first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| AEB1102 Dose Escalation Cohort 1 | Experimental | Drug: Co-ArgI-PEG3 patients dosed at 0.01 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 2 | Experimental | Drug: Co-ArgI-PEG4 patients dosed at 0.02 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 3 | Experimental | Drug: Co-ArgI-PEG4 patients dosed at 0.04 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 4 | Experimental | Drug: Co-ArgI-PEG4 patients dosed at 0.08 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 5 | Experimental | Drug: Co-ArgI-PEG3 patients dosed at 0.12 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 6 | Experimental | Drug: Co-ArgI-PEG4 patients dosed at 0.18 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 7 | Experimental | Drug: Co-ArgI-PEG5 patients dosed at 0.27 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 8 | Experimental | Drug: Co-ArgI-PEG7 patients dosed at 0.40 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 9 | Experimental | Drug: Co-ArgI-PEG7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg |
| AEB1102 Expansion Cutaneous | Experimental | Drug: Co-ArgI-PEG11 Cutaneous Melanoma patients dosed at 0.33 mg/kg |
| AEB1102 Expansion Uveal | Experimental | Drug: Co-ArgI-PEG12 Uveal Melanoma patients dosed at 0.33 mg/kg |
| AEB1102 Expansion SCLC | Experimental | Drug: Co-ArgI-PEG13 SCLC patients dosed at 0.33 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Co-ArgI-PEGAlso: AEB1102Administered IV | Drug | AEB1102 Dose Escalation Cohort 1, AEB1102 Dose Escalation Cohort 2, AEB1102 Dose Escalation Cohort 3, AEB1102 Dose Escalation Cohort 4, AEB1102 Dose Escalation Cohort 5, AEB1102 Dose Escalation Cohort 6, AEB1102 Dose Escalation Cohort 7, AEB1102 Dose Escalation Cohort 8, AEB1102 Dose Escalation Cohort 9, AEB1102 Expansion Cutaneous, AEB1102 Expansion SCLC, AEB1102 Expansion Uveal |
Primary outcome
maximum tolerated dose
Time frame: 4 weeks
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
1 secondary outcome
safety profile (changes in physical exam, laboratory measures, reported adverse events)
Time frame: 4 weeks +
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mattias Rudebeck, PhD MSc BMedSc study director
Immedica Pharma AB
11 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 Co-ArgI-PEG in people with Advanced Cancers, run by Immedica Pharma AB at 11 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 17 inclusion and 7 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: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose (time frame: 4 weeks). 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 6 Aug 2026.