NCT07788222 Mocaciclib Triple 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 NCT07788222 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: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07788222 is a hot trial to watch

Triple Negative Breast Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07788222 is notable because it evaluates Mocaciclib in a Phase 2 design sponsored by Yonsei University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This is a multicenter, open-label, single-arm phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab govitecan (SG) in combination with Q901 in patients with advanced (metastatic/recurrent/unresectable) triple-negative breast cancer (TNBC) whose disease has progressed following prior therapy, in the third-line treatment setting. Subjects enrolled in this trial must be patients diagnosed with advanced TNBC who have received at least 2 prior lines of systemic anticancer therapy, which may include chemotherapy, targeted therapy, or immunotherapy. However, for subjects who received adjuvant/neoadjuvant chemotherapy for resectable-stage breast cancer and relapsed within 12 months after completion of the last chemotherapy, the adjuvant/neoadjuvant chemotherapy is counted as one line of therapy. There are no restrictions on the type or sequence of prior therapies, but all subjects must have measurable disease per R

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 48 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.

• Objective Response Rate, ORR by RECIST v1.1 (Up to 24 months) — Objective response rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) as best overall response per RECIST v1.1. Tumor response is assessed by CT or MRI every 8 weeks, and responses are confirmed by imaging performed at least 4 weeks apart

Readout outlook and evidence gap

The current protocol points to Not reported 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: Mocaciclib is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Yonsei University is resolved to a normalized organization record in South Korea. 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

NCT07788222 provides a focused lens on Triple Negative Breast Cancer development. Its value will be determined by whether Mocaciclib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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