Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Callio Therapeutics
Registry number NCT07300943
Started 19 March 2026 Today 16 October 2026 Estimated completion 31 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Scientia Clinical Research Randwick NSW Recruiting
Integrated Clinical Oncology Network Pty Ltd South Brisbane QLD Recruiting
Peter Maccallum Cancer Centre Box Hill VIC Recruiting
AlfredHealth Heidelberg VIC Recruiting
Royal Melbourne Hospital Melbourne VIC Recruiting
Linear Clinical Research Ltd Nedlands WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 306

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Patients with advanced solid tumors

* Patients must have metastatic or unresectable disease not suitable for further local treatment and should have received prior beneficial therapies unless ineligible, unwilling, or lacking access.

* LVEF ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.

* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

* Measurable disease per RECIST version 1.1 at baseline

Exclusion Criteria:

* Prior anti-tumor treatment with an ATRi.

* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, and Stage I uterine cancer.

* History of uncontrolled seizure disorders or clinically significant neurodegenerative disorders, including progressive peripheral neuropathy. Stable Grade ≤ 2 peripheral neuropathy is allowed.

* Clinically significant autoimmune disease, either currently present or present within the previous 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to \>10 mg/prednisone daily (local immunosuppressive therapy such as inhaled or topical corticosteroids is allowed).

* Any uncontrolled Grade ≥ 3 (per NCI CTCAE version 6.0) viral, bacterial, or fungal infection within 2 weeks prior to Cycle 1 Day 1. Routine antimicrobial prophylaxis is permitted.

* History of hepatic cirrhosis, autoimmune hepatitis, or drug-associated hepatitis within the past 12 months.

* Uncontrolled diabetes mellitus, defined as Hgb A1c ≥8% or Hgb A1c between 7% and \<8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.

* Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.

Additional protocol defined inclusion/exclusion criteria may apply

Dates on the record

Started 19 March 2026
Estimated completion 31 December 2027
Registry last updated 1 May 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 1 May 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.