Evaluation of XYA02 in Patients With Advanced Solid Tumors

NCT07670312 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: XYA02-100
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 5

Brief Summary

This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.

Conditions

MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors; Non-Small Cell Lung Cancer; Ovarian Cancer; GEJ Adenocarcinoma; Colorectal Cancer; Pancreatic Adenocarcinoma

Keywords

MUC-1; solid tumor; Non-Small Cell Lung Cancer; Ovarian; GEJ adenocarcinoma; Colorectal; Pancreatic

Outcome Measures

Primary Outcomes (4)

• Frequency of Treatment Emergent Adverse Events of XYA02

  Frequency of Treatment Emergent Adverse Events \[Safety and Tolerability\]

  From enrollment for a minimum of 16 weeks

• Duration of Treatment Emergent Adverse Events of XYA02

  Length of duration of Treatment Emergent Adverse Events (start date to end date) \[Safety and Tolerability\]

  From enrollment for a minimum of 16 weeks

• Severity of Treatment Emergent Adverse Events of XYA02

  Severity by grading of Treatment Emergent Adverse Events \[Safety and Tolerability\]

  From enrollment for a minimum of 16 weeks

• Determine the Maximum Tolerated Dose (MTD) of XYA02

  Frequency of DLT occurring during participant exposure to XYA02

  From enrollment to a minimum of 16 weeks per participant

Secondary Outcomes (17)

• Anti-tumor activity of XYA02

  Measured at 6-week intervals for 6 months post enrollment and up to 2 years

• Anti-tumor activity of XYA02

  Measured at 6-week intervals for 6 months post enrollment and up to 2 years

• Anti-tumor activity of XYA02

  Measured at 6-week intervals for 6 months post enrollment and up to 2 years

• Anti-tumor activity of XYA02

  Measured at 6-week intervals for 6 months post enrollment and up to 2 years

• Determine the PK profile of XYA02

  PK sampling Cycles 1 and 3 (each cycle is 21 days) at Pre-dose, End of Infusion, 2 hours (h), 4h, 6h, 24h, 48h, 168h, 336h up to 12 weeks

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Participants with locally advanced, relapsed, or refractory tumors who will receive an intravenous (IV) infusion of XYA02.

Biological: XYA02

Dose Expansion

EXPERIMENTAL

Multiple expansion cohorts targeting various advanced solid tumors who will receive an intravenous (IV) infusion of XYA02.

Biological: XYA02

Interventions

XYA02 BIOLOGICAL

IV infusion

Dose Escalation; Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form(s) (ICFs) obtained at Screening.
• Has an eligible relapsed/refractory tumor with measurable disease based on RECIST 1.1 at Screening.
• Age ≥18 years at Screening and confirmed at the discretion of the Investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.
• Platelet (PLT) count ≥100,000/mcL at Screening.
• Hemoglobin ≥9.5 g/dL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.
• Absolute neutrophil count (ANC) ≥1,500/mcL at Screening.
• Estimated creatinine clearance (CrCl) \>60 mL/min at Screening. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.
• \. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.
• \. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.
• \. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.
• \. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography \[CT\] unless evidence of regrowth/disease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.
• \. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.
• \. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric/esophageal/GEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric/esophageal/GEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).
• \. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced/unresectable or metastatic at Screening according to the following criteria:

You may not qualify if:

• Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.
• Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \< 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.
• Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.
• Has a QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 millisecond (ms) in males and \> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.
• Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.
• Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.
• Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.
• Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.
• Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).
• Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions \> 20 mm in size.
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).
• Has a concomitant medical condition that would increase the risk of toxicity at Screening.
• Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.
• Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.

Sponsors & Collaborators

• XYone Therapeutics, Inc: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (5)

Chris O'Brien Life House

Sydney, New South Wales, Australia

Location

Westmead Hospital

Sydney, New South Wales, Australia

Location

Monash Medical Centre

Melbourne, Victoria, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

Linear Clinical Research

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Patrick A Zweidler-McKay, MD/PhD

  XYone Therapeutics, Inc

  STUDY DIRECTOR

Central Study Contacts

Tiffany Sepp

CONTACT

617-710-0770; clinicaltrial@xyonetx.com

Anshu Goyal

CONTACT

917-445-1846; clinicaltrial@xyonetx.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

Model Details: Open label study: Part 1 of the study will be dose escalation (determine MTD) and Part 2 of the study will be dose expansion.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 26, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)