Advanced MalignancyPhase 1NCT07238075
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
A Phase 1 study testing ADCX-020 in people with Advanced Malignancy and Advanced Solid Cancers, run by Adcytherix SAS at 9 sites in 2 countries.
Trial summary
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate. This study is set up in multiple parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors
- What is being tested?
- ADCX-020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Feb 2026to 30 Nov 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
- Male and female participants ≥ 18 years of age
- Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available
- Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced/metastatic setting (not counting neoadjuvant/adjuvant treatment if completed >6 months prior to recurrence)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Radiologically measurable disease by RECIST v1.1
- Mandatory adequate tumor tissue sample available
- Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)
Who cannot join
- Known allergies/hypersensitivity/intolerance to or contraindication to exatecan, or any excipient
- Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload
- Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) <50%, myocardial infarction or uncontrolled/unstable angina
- Has clinically active central nervous system (CNS) metastases
- Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Active corneal disease, or history of corneal disease within 12 months prior to enrollment
- Other unacceptable abnormalities, medications or procedures as defined by protocol
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
Australia6 sites, 6 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland, 4575
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
- Recruiting
Tasman Oncology Research
Southport, Queensland, 4215
- Recruiting
Macquarie University
Sydney, New South Wales, 2109
- Recruiting
Blacktown Hospital
Sydney, New South Wales, 2148
Spain3 sites, 3 recruiting
- Recruiting
START Barcelona
Barcelona, Barcelona, 08023
- Recruiting
START Madrid FJD
Madrid, Madrid, 28040
- Recruiting
START Madrid CIOCC
Madrid, Madrid, 28050
About this study
Official title: A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a/b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.
This study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.
Read the detailed description
This is a first-in-human (FIH) open-label, multicenter, dose escalation and multiple cohort expansion Phase 1a/b study to investigate safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of ADCX-020 monotherapy in participants with relapsed or refractory solid tumors, or who are intolerant to standard of care.
During dose escalation, Phase 1a, participants will receive escalating doses of ADCX-020 to identify the MTD based on the observation of DLTs. Intermediate and higher dose levels as well as alternative dosing regimens may be investigated during this part of the study.
Dose expansion, Phase 1b, will be initiated with a dose optimization of ADCX-020 using two or more dose levels of ADCX-020 and/or evaluating a different dosing regimen. Expansion in multiple cohorts is planned for selected patient populations using the RP2D.
Phase 1a will be overseen by a Dose Escalation Committee (DEC) and Phase 1b will be overseen by a Safety Review Committee (SRC).
- Being tested
- ADCX-020
- Keywords
- Antibody Drug Conjugate, Antineoplastic Agents, Monoclonal Antibodies, Neoplasms, Response Evaluation Criteria in Solid Tumors (RECIST), Phase 1 clinical trial, Maximum Tolerated Dose, Open-Label Trials, Multicenter Study, Pharmacokinetics, Pharmacodynamics, Drug-Related Side Effects and Adverse Reactions, Dose-Response Relationship, Drug, Adults, Progression-Free Survival / Overall Survival, Overall response rate
- Medical subject headings
- Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCX-020Drug
ADC
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a ADCX-020 | Experimental | Dose escalation of ADCX-020, intravenous Receives: Drug: ADCX-020 |
| Phase 1b: ADCX-020 | Experimental | Dose optimization and expansion of ADCX-020, intravenous Receives: Drug: ADCX-020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph1a: To determine the safety and tolerability of ADCX-020
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Start of treatment until 30 days after last dose
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization
Incidence of dose-limiting toxicities (DLTs) at different dose levels
Measured: Start of treatment to end of DLT observation period
Ph1b: To determine the recommended Phase 2 dose (RP2D)
Cumulative incidence and severity of TEAEs, preliminary anti-tumor activity and pharmacokinetics and -dynamics findings
Measured: Baseline to 30 days post last study drug administration
Ph1b: To assess the objective response rate (ORR) of ADCX-020
Preliminary efficacy based on ORR assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)
Secondary outcomes (9)
To evaluate duration of objective response (DoR)
DoR is defined as the time from first documented response to the date of first PD or death due to any cause
Measured: Baseline until approximately 24 months
To evaluate the disease control rate (DCR)
DCR is defined as the proportion of participants who achieved an objective response or stable disease, per RECIST v1.1.
Measured: Baseline until approximately 24 months
To assess prgression free survival (PFS)
PFS is defined as the time from first dose date to the date of first documented disease progression per RECIST v1.1 or death due to any cause
Measured: Baseline until approximately 24 months
Phase 1b: To evaluate overall survival (OS)
OS as time from study start to the date of death due to any cause
Measured: Baseline to approximately 24 months
To determine the plasma concentration of ADCX-020
PK analysis for Cmax and Cmin
Measured: Start of treatment until 30 days after last dose
To determine the time to Cmax (Tmax) for ADCX-020
PK analysis for Tmax
Measured: Start of treatment until 30 days after last dose
To determine the terminal phase elimination half-life (t1/2) for ADCX-020
PK analysis for t1/2
Measured: Start of treatment until 30 days after last dose
To determine the area under the plasma concentration-time curve (AUC) for ADCX-020
PK analysis for AUC
Measured: Start of treatment until 30 days after last dose
To evaluate the immunogenicity of ADCX-020
Frequency of participants developing anti-ADCX-020 antibodies and titer assessments
Measured: Start of treatment until 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start23 Feb 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignancyStudies 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
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adcytherix SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adcytherix, Study director, Adcytherix SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238075
- Sponsor's protocol ID
- ADCX-020-01
- Other IDs
- 2025-523959-65-00, 2025
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a/b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07238075
- Acronym / sponsor ID
- ADCX-020-01
- Keywords
- Antibody Drug Conjugate, Antineoplastic Agents, Monoclonal Antibodies, Neoplasms, Response Evaluation Criteria in Solid Tumors (RECIST), Phase 1 clinical trial, Maximum Tolerated Dose, Open-Label Trials
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Adcytherix SASIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 20 Nov 2025 (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 purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.
This study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.
Detailed description
This is a first-in-human (FIH) open-label, multicenter, dose escalation and multiple cohort expansion Phase 1a/b study to investigate safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of ADCX-020 monotherapy in participants with relapsed or refractory solid tumors, or who are intolerant to standard of care.
During dose escalation, Phase 1a, participants will receive escalating doses of ADCX-020 to identify the MTD based on the observation of DLTs. Intermediate and higher dose levels as well as alternative dosing regimens may be investigated during this part of the study.
Dose expansion, Phase 1b, will be initiated with a dose optimization of ADCX-020 using two or more dose levels of ADCX-020 and/or evaluating a different dosing regimen. Expansion in multiple cohorts is planned for selected patient populations using the RP2D.
Phase 1a will be overseen by a Dose Escalation Committee (DEC) and Phase 1b will be overseen by a Safety Review Committee (SRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a ADCX-020 | Experimental | Drug: ADCX-020Dose escalation of ADCX-020, intravenous |
| Phase 1b: ADCX-020 | Experimental | Drug: ADCX-020Dose optimization and expansion of ADCX-020, intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female participants ≥ 18 years of age
- Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available
- Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced/metastatic setting (not counting neoadjuvant/adjuvant treatment if completed >6 months prior to recurrence)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Radiologically measurable disease by RECIST v1.1
Key exclusion criteria (7 listed)
- Known allergies/hypersensitivity/intolerance to or contraindication to exatecan, or any excipient
- Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload
- Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) <50%, myocardial infarction or uncontrolled/unstable angina
- Has clinically active central nervous system (CNS) metastases
- Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
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 |
|---|---|---|
| ADCX-020ADC | Drug | Phase 1a ADCX-020, Phase 1b: ADCX-020 |
Primary outcome
Ph1a: To determine the safety and tolerability of ADCX-020
Time frame: Start of treatment until 30 days after last dose
Incidence and severity of treatment-emergent adverse events (TEAEs)
Ph1a: To determine the maximun tolerated dose (MTD) or recommended dose range for expansion and optimization
Time frame: Start of treatment to end of DLT observation period
Incidence of dose-limiting toxicities (DLTs) at different dose levels
Ph1b: To determine the recommended Phase 2 dose (RP2D)
Time frame: Baseline to 30 days post last study drug administration
Cumulative incidence and severity of TEAEs, preliminary anti-tumor activity and pharmacokinetics and -dynamics findings
Ph1b: To assess the objective response rate (ORR) of ADCX-020
Time frame: Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)
Preliminary efficacy based on ORR assessed by Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
9 secondary outcomes
To evaluate duration of objective response (DoR)
Time frame: Baseline until approximately 24 months
To evaluate the disease control rate (DCR)
Time frame: Baseline until approximately 24 months
To assess prgression free survival (PFS)
Time frame: Baseline until approximately 24 months
Phase 1b: To evaluate overall survival (OS)
Time frame: Baseline to approximately 24 months
To determine the plasma concentration of ADCX-020
Time frame: Start of treatment until 30 days after last dose
To determine the time to Cmax (Tmax) for ADCX-020
Time frame: Start of treatment until 30 days after last dose
To determine the terminal phase elimination half-life (t1/2) for ADCX-020
Time frame: Start of treatment until 30 days after last dose
To determine the area under the plasma concentration-time curve (AUC) for ADCX-020
Time frame: Start of treatment until 30 days after last dose
To evaluate the immunogenicity of ADCX-020
Time frame: Start of treatment until 30 days after last dose
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 8 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignancy
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Adcytherix study director
Adcytherix SAS
9 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 ADCX-020 in people with Advanced Malignancy and Advanced Solid Cancers, run by Adcytherix SAS at 9 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 7 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, Spain. 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 Adcytherix SAS (+31 628839232, clinicaltrials@adcytherix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ph1a: To determine the safety and tolerability of ADCX-020 (time frame: Start of treatment until 30 days after last dose). The study lists 4 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 8 Jun 2026.