Solid Tumors (Phase 1)Phase 1NCT07362888
First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors
A Phase 1 study testing ADCE-B05 in people with Solid Tumors (Phase 1), run by Adcendo ApS at 7 sites in 2 countries.
Trial summary
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors (Phase 1)
- What is being tested?
- ADCE-B05
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Mar 2026to 14 Mar 2029
- 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 or cytologically confirmed diagnosis of solid tumor
- Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
- Radiologically or clinically determined progressive disease during or after most recent line of therapy
- Measurable disease per RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate hematological and biochemical parameters
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate
- A female patient who is not pregnant, not breast feeding, and either not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment
Who cannot join
- Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
- Prior treatment with an ADC containing a topoisomerase I inhibitor payload
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
- Other malignancy
- Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
- Ongoing systemic infection requiring treatment with antibiotics, antivirals, or antimycotics, other than prophylactic treatment
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- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
- Clinically significant cardiovascular disease
- Acute infection with human immunodeficiency virus (HIV)-1 or HIV-2
- Current active liver disease due to hepatitis B or hepatitis C
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or pulmonary lymphangitic carcinomatosis
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Australia4 sites, 4 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
- Recruiting
Monash Health
Clayton, Victoria, 3165
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Scientia Clinical Research
Randwick, New South Wales, 2031
United States3 sites, 3 recruiting
- Recruiting
University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Yale University
New Haven, Connecticut, 06520
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
About this study
Official title: A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Read the detailed description
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
- Conditions
- Solid Tumors (Phase 1)
- Being tested
- ADCE-B05
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCE-B05Drug
Biological: Antibody-drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| ADCE-B05 | Experimental | Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle Receives: Drug: ADCE-B05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD/maximum administered dose of ADCE-B05
Incidence of dose-limiting toxicities (DLTs)
Measured: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
Assess the safety and tolerability of ADCE-B05
Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0).
Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Secondary outcomes (11)
Maximum concentration (Cmax)
The maximum concentration (Cmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to maximum concentration (Tmax)
The time to maximum concentration (Tmax) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Terminal half-life (T[1/2])
The terminal half-life (T[1/2]) will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Area under the concentration-time curve (AUC)
The area under the concentration-time curve (AUC) will be assessed to characterize PK profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Total antibody (TAb)
The total antibody will be assessed to characterize the Pharmacokinetic profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Free (de-conjugated) payload
The free (de-conjugated) payload will be assessed to characterize PK profile of ADCE-B05
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR)
Objective response rate (ORR) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response (DOR)
Duration of response DOR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Progression-free survival (PFS)
Progression-free survival (PFS) will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Disease Control Rate (DCR)
DCR will be assessed by investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to Response (TTR)
TTR will be assessed by Investigator per RECIST v1.1 to evaluate preliminary antitumor activity
Measured: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start17 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors (Phase 1)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adcendo ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362888
- Sponsor's protocol ID
- ADCE-B05-001
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2026
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1a/1b, Open-Label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of the Antibody Drug Conjugate ADCE-B05 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07362888
- Acronym / sponsor ID
- ADCE-B05-001
- Conditions
- Solid Tumors (Phase 1)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Adcendo ApSIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 23 Jan 2026 (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.
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability of ADCE-B05 when given as a single therapy over a range of different dose levels.
Detailed description
Safety and tolerability will be evaluated by incidence of DLTs. Efficacy will be evaluated by antitumor activity: ORR, DOR, PFR, and TTR per RECIST v 1.1
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADCE-B05 | Experimental | Drug: ADCE-B05Dose escalation followed by a dose expansion phase. ADCE-B05 is administered intravenously on a 3 weekly dosing cycle |
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 or cytologically confirmed diagnosis of solid tumor
- Advanced disease (i.e., unresectable locally advanced or metastatic) and refractory to, intolerant of, or ineligible for approved therapies
- Radiologically or clinically determined progressive disease during or after most recent line of therapy
- Measurable disease per RECIST 1.1
- ECOG performance status of 0 or 1
Key exclusion criteria (11 listed)
- Treatment with systemic anticancer therapy, including any investigational agent within 3 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration
- Prior treatment with an ADC containing a topoisomerase I inhibitor payload
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required
- Other malignancy
- Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
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 |
|---|---|---|
| ADCE-B05Biological: Antibody-drug conjugate (ADC) | Drug | ADCE-B05 |
Primary outcome
Determine the MTD/maximum administered dose of ADCE-B05
Time frame: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)
Incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-B05
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation
11 secondary outcomes
Maximum concentration (Cmax)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to maximum concentration (Tmax)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Terminal half-life (T[1/2])
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Area under the concentration-time curve (AUC)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Total antibody (TAb)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Free (de-conjugated) payload
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Objective response rate (ORR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Duration of response (DOR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Progression-free survival (PFS)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Disease Control Rate (DCR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Time to Response (TTR)
Time frame: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
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 24 Jul 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADCE-B05 in people with Solid Tumors (Phase 1), run by Adcendo ApS at 7 sites in 2 countries.
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 11 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 24 Jul 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 Australia, 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 Charlotte Lybek Lind (+45 26461897, charlotte.lind@adcendo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD/maximum administered dose of ADCE-B05 (time frame: From enrollment to the end of Phase 1a (Approximately 11 months after enrollment)). 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 24 Jul 2026.