DEM301 NCT07805369 Clinical Landscape 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: 16 September 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

60

Planned enrollment

2028-09-01

Primary-completion proxy

Executive view

NCT07805369 evaluates DEM301 in Rectal Cancer. The disclosed sponsor is DEM BioPharma, Inc., the design is Interventional, and the geographic footprint is Geography not reported. The first listed primary endpoint is Incidence of Dose-Limiting Toxicities (DLTs), assessed over 21 Days.

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 NCT07805369 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Rectal Cancer landscape. Drug & Asset MCP drug_fetch was queried for DEM301, while Company & Deal Intelligence MCP organization_fetch was queried for DEM BioPharma, Inc..

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
NCT07805369	DEM301	Phase 1 / Not yet recruiting	DEM BioPharma, Inc.	Geography not reported	Incidence of Dose-Limiting Toxicities (DLTs) 21 Days	2028-09-01
NCT07807800	DES-1357	Phase 1/2 / Not yet recruiting	D.E. Shaw Research LLC	Geography not reported	Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) Part 1: Cycle 1 (Cycle length=21 days)	2028-07-02
NCT07808151	Pembrolizumab	Phase 2 / Not yet recruiting	Solstice Oncology, Inc.	Netherlands, Belgium, United States, United Kingdom, Italy, Spain	Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR) Assessed from surgical resection specimen (surgery occurs Day 42-Day…	2029-09-30
NCT07808177	177Lu-FAP-VG11	Early Phase 1 / Recruiting	Shandong First Medical University Affiliated Tumor Hospital (Shandong Cancer Research Institute Shandong Tumor Hospital)	China	Dose-Limiting Toxicities (DLT) Through study completion, assessed up to 2 years.	2027-05-06
NCT07805551	HDM-2017	Phase 1/2 / Recruiting	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	China	Maximum Tolerated Dose (MTD) 30 days after the last dose of IMP	2030-08-01

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

NCT07805369 is a Phase 1, not yet recruiting study with 60 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.

The primary endpoint is “Incidence of Dose-Limiting Toxicities (DLTs)” over “21 Days.” The retrieved endpoint description is: Incidence of DLTs in DLT-evaluable participants enrolled in Dose Escalation..

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 60 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 Rectal Cancer. These records do not establish direct evidence for NCT07805369 unless the registration number matches.

Randomized phase-II trial of surufatinib plus FOLFOX/FOLFIRI versus FOLFOXIRI as second-line therapy for metastatic colorectal cancer

Phase 2; n=57; ORR = 39.3 % ( 21.5 - 59.4); ORR = 35.7 % ( 18.6 - 55.9) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42421558/

Phase II Study of Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma

Phase 2; n=11; No numerical result field reported Source: https://clinicaltrials.gov/ct2/show/results/NCT02023333

Aspirin for cancer prevention in individuals with Lynch syndrome: first results from the CaPP3 multicentre, randomised, double-blind, non-inferiority trial

Phase 3; n=1879; Lynch syndrome cancers = 75.0 Participant ; Lynch syndrome cancers = 57.0 Participant Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42425127/

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

DEM301 is indexed as Antibody drug conjugate (ADC) with target not reported biology and a global stage of Phase 1. The asset profile lists DEM BioPharma, Inc. as an originator or developer.

DEM BioPharma, Inc. is indexed in United States with the website https://dembiopharma.com. DEM BioPharma is an immuno-oncology company that is working to eradicate cancer by targeting novel innate immune system checkpoints. The record lists 5 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 DEM301 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: NCT07805369
Protocol source: https://clinicaltrials.gov/study/NCT07805369
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: 16 September 2026.

DEM301 in Rectal Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of Dose-Limiting Toxicities (DLTs) and 2028-09-01 the leading decision points.

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