NCT07730125 CRG-150 PIK3CA mutation/HR-positive/HER2-negative Breast Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07730125 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07730125 is a hot trial to watch
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07730125 is notable because it evaluates CRG-150 in a Phase 1/2 design sponsored by CoRegen, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07730125 |
| Official title | Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies |
| Phase / status | Phase 1/2 / Not yet recruiting |
| Intervention | CRG-150 |
| Sponsor | CoRegen, Inc. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Proportion of patients with DLTs within 28 days from first infusion and overall safety |
| Endpoint time frame | *DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this Phase 1/2a observational study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are: Phase 1 * Incidence of DLTs * Incidence of CRG-150 related AEs and SAEs * Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a * HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment * Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: • CRG-150 cells at the assigned dose
Allocation is N/A, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Proportion of patients with DLTs within 28 days from first infusion and overall safety (*DLTs: within 28 days from first cell infusion. *Incidence of AEs: Up to 15 years *Incidence of SAEs: Up to 15 years) — * The proportion of patients with DLTs occurring within 28 days from first cell infusion will be calculated for each dose level * Overall safety: type, frequency, and severity of SAEs (IRRs, immune reactions, new malignancies, AEs leading to death, and DLTs), and of treatment-related AEs and systemic reactions
- Determine the recommended phase 2 dose (RP2D) of CRG-150 (Up to 1-year post-infusion) — RP2D, as determined through the dose escalation process for the specified indications
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: CRG-150 is indexed as Tregs cell therapy, with target NCOA3, mechanism NCOA3 inhibitors, and global highest development status Phase 1/2.
Company & Deal Intelligence MCP profile: CoRegen, Inc. is resolved to a normalized organization record in PITKIN COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07730125 provides a focused lens on PIK3CA mutation/HR-positive/HER2-negative Breast Cancer development. Its value will be determined by whether CRG-150 can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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