NCT07680569 Leucovorin Calcium Advanced Gastric Adenocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07680569 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 NCT07680569 is a hot trial to watch

Advanced Gastric Adenocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07680569 is notable because it evaluates Leucovorin Calcium in a Phase 1/2 design sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. 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 an open-label, dose-escalation and dose-expansion phase Ib/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination therapies in subjects with gastric or GEJ adenocarcinoma. A total of about 40 subjects will be enrolled in this study. Part-I: Dose-Escalation Phase (Phase Ib) This phase includes Screening, Treatment, and Follow-up Periods: Screening Period: Screening period is up to 28 days (D-28 to D-1) prior to receiving the first dose of HCB101. Treatment Period: This period includes repeat dosing treatment period (42 days per cycle). During the treatment period, subjects from different cohorts will receive HCB101 in combination therapy. Treatment will continue until one of the following occurs: unacceptable adverse event (AE), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whenever occurs

Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel 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.

• Number/incidence and percentage of subjects with AEs, SAEs and TEAEs. (From signing the ICF at Screening until 30 days after the last administration of the study intervention or Safety Follow-up Visit with an expected observation period of 2 years.) — To evaluate the safety and tolerability of HCB101 in combination with zolbetuximab and standard-of-care therapies.
• MTD or RP2D of HCB101 in combination therapy (From 1st dose to Cycle 1 Day 28 (each cycle is 42 days).) — To determine the MTD or RP2D of HCB101 in combination therapy

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: Leucovorin Calcium is indexed as Small molecule drug, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status Approved.

Company & Deal Intelligence MCP profile: Kaohsiung Medical University Chung-Ho Memorial Hospital did not return an exact normalized organization match in this snapshot. 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

NCT07680569 provides a focused lens on Advanced Gastric Adenocarcinoma development. Its value will be determined by whether Leucovorin Calcium 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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