GEN-3018 in Acute Myeloid Leukemia: NCT07384715 Clinical Landscape Report 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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
78
Planned enrollment
2029-10-18
Primary-completion proxy
Executive view
NCT07384715 evaluates GEN-3018 in Acute Myeloid Leukemia. The disclosed sponsor is Genmab A/S, the design is Interventional, and the geographic footprint is Denmark, Spain. The first listed primary endpoint is Part 1: Number of Participants with Dose-limiting Toxicities (DLTs), assessed over 28 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 NCT07384715 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Acute Myeloid Leukemia landscape. Drug & Asset MCP drug_fetch was queried for GEN-3018, while Company & Deal Intelligence MCP organization_fetch was queried for Genmab A/S.
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 |
|---|---|---|---|---|---|---|
| NCT07384715 | GEN-3018 | Phase 1 / Recruiting | Genmab A/S | Denmark, Spain | Part 1: Number of Participants with Dose-limiting Toxicities (DLTs) 28 days | 2029-10-18 |
| NCT07471789 | CD84 Targeted CART(Gyala Therapeutics) | Phase 1/2 / Recruiting | Gyala Therapeutics SL | Spain | Number of Participants with Adverse Events. 2 years | 2029-05-31 |
| NCT07463768 | Ivosidenib | Phase 2 / Not yet recruiting | Sponsor not reported | France | RFS 24 months 24 months | 2030-09-01 |
| NCT07464951 | Ruxolitinib Phosphate | Phase 1 / Recruiting | The Children's Hospital of Philadelphia | United States | Evaluate the Safety of CART123 5 years | 2029-05-14 |
| ACTRN12626000278336 | Venetoclax | Not Applicable / Not yet recruiting | Australasian Leukaemia & Lymphoma Group | Australia | Timing not reported |
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
NCT07384715 is a Phase 1, recruiting study with 78 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)” over “28 days.” No additional primary-endpoint description was returned in the selected field set.
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 78 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 Acute Myeloid Leukemia. These records do not establish direct evidence for NCT07384715 unless the registration number matches.
A Phase 1/2a, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety and Efficacy of GDX012 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1/2; n=16; Number of Participants With Dose Limiting Toxicities (DLTs) to Determine the Maximum Tolerated Dose (MTD) of GDX012 = 0 Participants ; Number of Participants With Dose Limiting Toxicities (DLTs) to Determine the Maximum Tolerated Dose (MTD) of GDX012 = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05886491
Vyxeos for Induction of Newly Diagnosed Low- or Intermediate-risk AML Patients, Age 18-70. A Pilot Study
Phase 2; n=20; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 6 Participants ; Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg. = 13 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05599360
Dordaviprone Maintenance After Allogeneic HCT for High‐Risk Acute Myeloid Leukemia and Myelodysplastic Neoplasm
Phase 1; n=20; AE(Grade ≥ 3) = 45.0 % Source: https://pubmed.ncbi.nlm.nih.gov/42359621/
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
GEN-3018 is indexed as Bispecific antibody with target not reported biology and a global stage of Phase 1. The asset profile lists Genmab A/S as an originator or developer.
Genmab A/S is indexed in Denmark with the website http://www.genmab.com. Genmab is a biotechnology company developing antibody-based therapies for cancer and other diseases.potential treatment of cancer. The record lists 21 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 GEN-3018 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: NCT07384715
Protocol source: https://clinicaltrials.gov/study/NCT07384715
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: 28 September 2026.
GEN-3018 in Acute Myeloid Leukemia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Part 1: Number of Participants with Dose-limiting Toxicities (DLTs) and 2029-10-18 the leading decision points.
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