TAK-505 in Locally Advanced Malignant Solid Neoplasm: NCT07436728 Clinical Landscape Report 2026

18 September 2026
9 min read

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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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 1/2

Clinical phase

Recruiting

Recruitment status

151

Planned enrollment

2030-08-18

Primary-completion proxy

Executive view

NCT07436728 evaluates TAK-505 in Locally Advanced Malignant Solid Neoplasm. The disclosed sponsor is Takeda Pharmaceutical Co., Ltd., the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs), assessed over From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1.

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 NCT07436728 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Locally Advanced Malignant Solid Neoplasm landscape. Drug & Asset MCP drug_fetch was queried for TAK-505, while Company & Deal Intelligence MCP organization_fetch was queried for Takeda Pharmaceutical 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

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07436728TAK-505Phase 1/2 / RecruitingTakeda Pharmaceutical Co., Ltd.United StatesPhase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
From initial dose until 28 days after infusion of the first cohort do…
2030-08-18
NCT07470853HWK-016Phase 1 / RecruitingWhitehawk Therapeutics, Inc.United StatesDetermine Maximum Tolerated Dose (MTD)
From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
2028-02-01
NCT07462663GLP-1 agonist (Nxera Pharma)Phase 4 / Not yet recruitingBellvitge University HospitalGeography not reportedRecruitment Rate
From study opening to end of recruitment, up to 36 months.
2031-04-01
NCT07453394OlaparibPhase 1/2 / Not yet recruitingQilu Pharmaceutical Co., Ltd.Geography not reportedIncidence and severity of adverse events
up to 2 years
2027-04-01
NCT07444814HWK-007Phase 1 / RecruitingWhitehawk Therapeutics, Inc.United StatesDetermine Maximum Tolerated Dose (MTD)
From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
2028-10-01

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

NCT07436728 is a Phase 1/2, recruiting study with 151 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.

The primary endpoint is “Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)” over “From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1.” The retrieved endpoint description is: DLTs are defined as specific Grade 3 and 4 hematologic and hepatic nonhematologic events or any other Grade ≥3 adverse events related to treatment that occur during the DLT evaluation period after administration of TAK-505, except events that are clearly due to the underlying disease or an extraneous cause..

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 151 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

5 recent result records were selected as contextual evidence for Locally Advanced Malignant Solid Neoplasm. These records do not establish direct evidence for NCT07436728 unless the registration number matches.

A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhib…

Phase 1/2; n=97; Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 = 62 Participants ; Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 = 3 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05572684

A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma

Phase 2; n=62; CBR = 27 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT01797523

A Phase Ib/II Open Label, Multi-arm, Parallel Cohort Dose Finding and Expansion Study to Assess the Safety, Pharmacokinetics and Efficacy of NUC-3373, a Nucleotide Analogue, Given…

Phase 1/2; n=19; Number of Participants With DLTs in Each Module = 0 Participants ; Number of Participants With DLTs in Each Module = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05714553

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

TAK-505 is indexed as gamma delta (γδ) T cell engager with PDL1 biology and a global stage of Phase 1/2. The asset profile lists Takeda Pharmaceutical Co., Ltd. as an originator or developer.

Takeda Pharmaceutical Co., Ltd. is indexed in Japan with the website http://www.takeda.com. Engages in the research, development, manufacturing and marketing of pharmaceutical products The record lists 243 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

  1. 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.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether TAK-505 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: NCT07436728
Protocol source: https://clinicaltrials.gov/study/NCT07436728
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: 18 September 2026.

TAK-505 in Locally Advanced Malignant Solid Neoplasm is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) and 2030-08-18 the leading decision points.

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