OZ-001 in Liver metastases: ACTRN12625000312448 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Not yet recruiting
Recruitment status
not reported
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
ACTRN12625000312448 evaluates OZ-001 in Liver metastases. The disclosed sponsor is Oncozen Co. Ltd., the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is not reported, assessed over an unreported time frame.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for ACTRN12625000312448 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Liver metastases landscape. Drug & Asset MCP drug_fetch was queried for OZ-001, while Company & Deal Intelligence MCP organization_fetch was queried for Oncozen Co. Ltd..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| ACTRN12625000312448 | OZ-001 | Phase 1 / Not yet recruiting | Oncozen Co. Ltd. | Australia | Timing not reported | |
| NCT06977542 | Ivonescimab | Phase 2 / Not yet recruiting | Fudan University | Geography not reported | pathological complete response rate (pCR) Up to approximately 24 weeks | 2029-01-01 |
| NCT06975644 | Albumin-Bound Paclitaxel | Not Applicable / Not yet recruiting | Zhejiang Provincial Peoples Hospital | Geography not reported | Pathological complete response six months | 2026-09-01 |
| NCT06976944 | Albumin-Bound Paclitaxel | Phase 2 / Recruiting | Japanese Foundation for Cancer Research | Japan | Progression free survival Through protocol treatment discontinuation, approximately 9 months | 2029-09-01 |
| NCT06966700 | Olaparib | Phase 3 / Recruiting | Merck Sharp & Dohme LLC | Singapore, Hong Kong, Czechia, United States, Malaysia, Thailand, Portugal, Saudi Arabia, Greece, Vietnam, Sweden, South Korea, China, Turkey, Poland, Guatemala, Brazil, France, Chile, Colombia, Argentina, Romania, Hungary, Philippines, Japan, Ukraine, United Kingdom, Spain, India, New Zealand, Canada, Belgium, Norway, Taiwan Province, Finland, South Africa, Italy, Israel, Australia, Peru, Germany | Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery Up to approximately 30 weeks | 2033-03-23 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
ACTRN12625000312448 is a Phase 1, not yet recruiting study with not reported planned participants. Allocation is Non-randomised trial, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: Composite Outcome: Phase 1b: To determine the safety and tolerability of OZ-001 when administered orally to patients with TNBC.[The incidence and severity of treatment-related adverse events (TEAEs) from Day 1 to 28 days after the last dose of OZ-001. Adverse Events will be graded using the most current version of the National Cancer Institute CTCAE 5- point scale and assessed continuously as they are reported or observed and reviewed daily from Day 1 until 28 days after last dose.].
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
0 recent result records were selected as contextual evidence for Liver metastases. These records do not establish direct evidence for ACTRN12625000312448 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
OZ-001 is indexed as Small molecule drug with STAT3 x T-type calcium channel biology and a global stage of Preclinical. The asset profile lists Oncozen Co. Ltd. as an originator or developer.
Oncozen Co. Ltd. is indexed in an unreported country with the website http://www.oncozen.co.kr. Oncogen is a venture company that specializes in research and development of new drugs. The record lists 7 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether OZ-001 is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: ACTRN12625000312448
Protocol source: https://anzctr.org.au/ACTRN12625000312448.aspx
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 15 October 2026.
OZ-001 in Liver metastases is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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