Fludarabine Phosphate in Metastatic castration-resistant prostate cancer: NCT07793435 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: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1/2
Clinical phase
Not yet recruiting
Recruitment status
12
Planned enrollment
2028-10-01
Primary-completion proxy
Executive view
NCT07793435 evaluates Fludarabine Phosphate in Metastatic castration-resistant prostate cancer. The disclosed sponsor is ADICET THERAPEUTICS INC, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is The incidence of Subjects with Dose Limiting Toxicity within each dose level, assessed over Day 42.
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 NCT07793435 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metastatic castration-resistant prostate cancer landscape. Drug & Asset MCP drug_fetch was queried for Fludarabine Phosphate, while Company & Deal Intelligence MCP organization_fetch was queried for ADICET THERAPEUTICS 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 |
|---|---|---|---|---|---|---|
| NCT07793435 | Fludarabine Phosphate | Phase 1/2 / Not yet recruiting | ADICET THERAPEUTICS INC | United States | The incidence of Subjects with Dose Limiting Toxicity within each dose level Day 42 | 2028-10-01 |
| NCT07783282 | Enzalutamide | Phase 1 / Not yet recruiting | Astellas Pharma Global Development, Inc. | Geography not reported | Pharmacokinetics (PK) of Fezolinetant in plasma: Maximum Concentration (Cmax) Up to Day 3 | 2027-04-30 |
| NCT07765940 | 64Cu-RAX301 | Phase 1/2 / Not yet recruiting | RadAlliance Therapeutics, Inc. | Geography not reported | The safety and tolerability of [⁶⁴Cu]Cu-RAX301 Injection - Phase 1 From administration of [⁶⁴Cu]Cu-RAX301 through Day 7 ± 2 days | 2027-06-30 |
| NCT07756593 | Nogapendekin alfa inbakicept-pmln | Phase 1 / Not yet recruiting | Washington University School of Medicine | United States | Frequency of dose-limiting toxicities (Cohort 1 only) Start of treatment (day 1 dose of Sip-T) through 14 days following th… | 2029-04-14 |
| NCT07751133 | Apalutamide | Phase 3 / Recruiting | University College London | United Kingdom | Overall survival (primary efficacy) From randomisation up to 6 years (or date last known to be alive) or… | 2029-08-01 |
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
NCT07793435 is a Phase 1/2, not yet recruiting study with 12 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “The incidence of Subjects with Dose Limiting Toxicity within each dose level” over “Day 42.” The retrieved endpoint description is: The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D).
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 12 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 Metastatic castration-resistant prostate cancer. These records do not establish direct evidence for NCT07793435 unless the registration number matches.
PLATI-PARP: A Phase 2 Study of Induction Docetaxel and Carboplatin Followed by Maintenance Rucaparib in Treatment of Patients With Metastatic Castration Resistant Prostate Cancer…
Phase 2; n=18; Radiographic Progression Free Survival Assessed by Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) Criteria(Median) = 8.1 Months (95% Confidence Interval, 6.5 - 31.2) Source: https://clinicaltrials.gov/ct2/show/results/NCT03442556
Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Usin…
Phase 2; n=223; PFS(Median): Hazard Ratio (HR) = 0.29(95% CI, 0.20 - 0.40), P-Value = <0.001; PFS(Median) = 14.3 Months (95% Confidence Interval, 11.20 - 17.38) Source: https://clinicaltrials.gov/ct2/show/results/NCT05059236
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients W…
Phase 3; n=1012; rPFS(Median) = 33.2 Months (95% Confidence Interval, 25.8 - 44.2); rPFS(Median): Hazard Ratio (HR) = 0.81(95% CI, 0.66 - 0.98), P-Value = 0.034 Source: https://clinicaltrials.gov/ct2/show/results/NCT04493853
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
Fludarabine Phosphate is indexed as Small molecule drug with Pol III x RNA polymerase II x RNRs biology and a global stage of Approved. The asset profile lists Southern Research Institute as an originator or developer.
ADICET THERAPEUTICS INC is indexed in United States. Operates as a biotechnology company The record lists 4 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 Fludarabine Phosphate 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: NCT07793435
Protocol source: https://clinicaltrials.gov/study/NCT07793435
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.
Fludarabine Phosphate in Metastatic castration-resistant prostate cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes The incidence of Subjects with Dose Limiting Toxicity within each dose level and 2028-10-01 the leading decision points.
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