ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Solid Tumors; Advanced Malignancy; Advanced Solid Cancers
• Intervention / Treatment: Drug: ADCX-020

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 Type: Interventional
• Enrollment (Estimated): 290
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Adcytherix SAS; Phone Number: +31 628839232; Email: clinicaltrials@adcytherix.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2148
      • Not yet recruiting
      • Blacktown Hospital
    • Sydney, New South Wales, Australia, 2109
      • Not yet recruiting
      • Macquarie University
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast University Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Not yet recruiting
      • Cancer Research SA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a ADCX-020; Dose escalation of ADCX-020, intravenous	Drug: ADCX-020; ADC
Experimental: Phase 1b: ADCX-020; Dose optimization and expansion of ADCX-020, intravenous	Drug: ADCX-020; ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ph1a: To determine the safety and tolerability of ADCX-020	Incidence and severity of treatment-emergent adverse events (TEAEs)	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	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	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	Baseline until the date of the first documented disease progression, death, or start of new anticancer therapy (approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	Baseline to approximately 24 months
To determine the plasma concentration of ADCX-020	PK analysis for Cmax and Cmin	Start of treatment until 30 days after last dose
To determine the time to Cmax (Tmax) for ADCX-020	PK analysis for Tmax	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	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	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	Start of treatment until 30 days after last dose

Collaborators and Investigators

• Sponsor: Adcytherix SAS
• Investigators: Study Director: Adcytherix, Adcytherix SAS

Study record dates

Study Major Dates

• Study Start (Estimated): February 14, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Neoplasms; Adults; Pharmacokinetics; Phase 1 clinical trial; Antineoplastic Agents; Pharmacodynamics; Drug-Related Side Effects and Adverse Reactions; Dose-Response Relationship, Drug; Antibody Drug Conjugate; Monoclonal Antibodies; Maximum Tolerated Dose; Multicenter Study; Overall response rate; Response Evaluation Criteria in Solid Tumors (RECIST); Open-Label Trials; Progression-Free Survival / Overall Survival
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: ADCX-020-01; 2025-523959-65-00 (Ctis)

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