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

NCT07238075 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: ADCX-020-012025-523959-65-00
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Advanced Solid Cancers; Metastatic Solid Tumors; Advanced Malignancy

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• To evaluate duration of objective response (DoR)

  Baseline until approximately 24 months

• To evaluate the disease control rate (DCR)

  Baseline until approximately 24 months

• To assess prgression free survival (PFS)

  Baseline until approximately 24 months

• Phase 1b: To evaluate overall survival (OS)

  Baseline to approximately 24 months

• To determine the plasma concentration of ADCX-020

  Start of treatment until 30 days after last dose

Study Arms (2)

Phase 1a ADCX-020

EXPERIMENTAL

Dose escalation of ADCX-020, intravenous

Drug: ADCX-020

Phase 1b: ADCX-020

EXPERIMENTAL

Dose optimization and expansion of ADCX-020, intravenous

Drug: ADCX-020

Interventions

ADCX-020 DRUG

ADC

Phase 1a ADCX-020; Phase 1b: ADCX-020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Adcytherix SAS: lead

Study Sites (4)

Macquarie University

Sydney, New South Wales, 2109, Australia

NOT YET RECRUITING

Blacktown Hospital

Sydney, New South Wales, 2148, Australia

NOT YET RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, 5000, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Adcytherix

  Adcytherix SAS

  STUDY DIRECTOR

Central Study Contacts

Adcytherix SAS

CONTACT

+31 628839232; clinicaltrials@adcytherix.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: February 14, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)