A Phase 1 interventional study of ADCX-020 in Advanced Malignancy, Advanced Solid Cancers and Metastatic Solid Tumors, sponsored by Adcytherix SAS. Recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Adcytherix SAS · Phase 1, Interventional, and Treatment
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.
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 290 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Adcytherix SAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose escalation of ADCX-020, intravenous
Drug: ADCX-020
Dose optimization and expansion of ADCX-020, intravenous
Drug: ADCX-020
ADC
Ph1a: To determine the safety and tolerability of ADCX-020
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline to approximately 24 months
To determine the plasma concentration of ADCX-020
PK analysis for Cmax and Cmin
Time frame: Start of treatment until 30 days after last dose
To determine the time to Cmax (Tmax) for ADCX-020
PK analysis for Tmax
Time frame: 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
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
PK analysis for AUC
Time frame: 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
Time frame: Start of treatment until 30 days after last dose
Plan to share: No
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