Raludotatug deruxtecan in HRD-positive Ovarian Cancer: NCT07776691 Clinical Landscape Report 2026

11 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: 11 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 3

Clinical phase

Not yet recruiting

Recruitment status

802

Planned enrollment

2032-03-19

Primary-completion proxy

Executive view

NCT07776691 evaluates Raludotatug deruxtecan in HRD-positive Ovarian Cancer. The disclosed sponsor is Merck Sharp & Dohme LLC, the design is Interventional, and the geographic footprint is Geography not reported. The first listed primary endpoint is Progression-Free Survival (PFS), assessed over Up to approximately 4 years.

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 NCT07776691 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider HRD-positive Ovarian Cancer landscape. Drug & Asset MCP drug_fetch was queried for Raludotatug deruxtecan, while Company & Deal Intelligence MCP organization_fetch was queried for Merck Sharp & Dohme LLC.

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
NCT07776691Raludotatug deruxtecanPhase 3 / Not yet recruitingMerck Sharp & Dohme LLCGeography not reportedProgression-Free Survival (PFS)
Up to approximately 4 years
2032-03-19
NCT07811271Bevacizumab biosimilar (Bio-Thera Solutions)Phase 3 / Not yet recruitingBeOne Medicines Ltd.Geography not reportedProgression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Up to 5 years
2029-11-30
NCT07814248Tumor-Targeted Drug Conjugate(TwoStep)Phase 1 / Not yet recruitingTwoStep Therapeutics, Inc.Geography not reportedNumber of Participants with Adverse Events Following Administration of TS-104
From the first dose of TS-104 until 28 days after the last dose of TS…
2028-08-01
NCT07807956ABBV-253Phase 1 / Not yet recruitingAbbVie, Inc.Geography not reportedNumber of Participants With Adverse Events
Up to approximately 4 years
2029-12-01
NCT07778498TJ-102 (Phrontline)Phase 1/2 / Not yet recruitingPhrontline Biopharma (Suzhou) Co., Ltd.Geography not reportedNumber of participants with Dose-limiting toxicities
2 years
2029-09-01

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

NCT07776691 is a Phase 3, not yet recruiting study with 802 planned participants. Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment.

The primary endpoint is “Progression-Free Survival (PFS)” over “Up to approximately 4 years.” The retrieved endpoint description is: PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD..

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 802 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

The protocol identifies Bevacizumab as control therapy. 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

4 recent result records were selected as contextual evidence for HRD-positive Ovarian Cancer. These records do not establish direct evidence for NCT07776691 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 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Granulosa Cell Tumors

Phase 2; n=53; ORR = 0 percentage of participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05348356

Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Phase 2; n=40; PFS(Median) = 2.8 Months (Inter-Quartile Range, 2.1 - 7.7); PFS(Median): P-Value = 0.03 Source: https://clinicaltrials.gov/ct2/show/results/NCT05979298

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

No exact Drug & Asset MCP profile was returned for the protocol wording “Raludotatug deruxtecan.” The report therefore avoids inferring modality, target or global development stage from the name alone.

No exact Company & Deal Intelligence profile was returned for Merck Sharp & Dohme LLC. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.

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 Raludotatug deruxtecan 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: NCT07776691
Protocol source: https://clinicaltrials.gov/study/NCT07776691
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: 11 September 2026.

Raludotatug deruxtecan in HRD-positive Ovarian Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Progression-Free Survival (PFS) and 2032-03-19 the leading decision points.

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