Pembrolizumab biosimilar(Henlius) in Renal Cell Carcinoma: NCT07160335 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
Active, not recruiting
Recruitment status
174
Planned enrollment
2027-04-30
Primary-completion proxy
Executive view
NCT07160335 evaluates Pembrolizumab biosimilar(Henlius) in Renal Cell Carcinoma. The disclosed sponsor is Shanghai Henlius Biotech, Inc., the design is Interventional, and the geographic footprint is United States, China, Turkey. The first listed primary endpoint is AUC0-21d, assessed over rom time 0 to 21 days after the 1st dose (3 weeks).
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 NCT07160335 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Renal Cell Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for Pembrolizumab biosimilar(Henlius), while Company & Deal Intelligence MCP organization_fetch was queried for Shanghai Henlius Biotech, 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 |
|---|---|---|---|---|---|---|
| NCT07160335 | Pembrolizumab biosimilar(Henlius) | Phase 1 / Active, not recruiting | Shanghai Henlius Biotech, Inc. | United States, China, Turkey | AUC0-21d rom time 0 to 21 days after the 1st dose (3 weeks) | 2027-04-30 |
| NCT07218692 | RP-2(Replimune Group) | Phase 2 / Not yet recruiting | City of Hope National Medical Center | United States | Objective response rate Up to 2 years | 2027-08-11 |
| NCT07195682 | Ipilimumab | Phase 1 / Recruiting | Bristol Myers Squibb Co. | Canada, United States, Italy, France, Spain | Number of Participants With Adverse Events (AEs) Up to approximately 2 years from first dose of BMS-986506 | 2030-05-03 |
| NCT07197580 | Lutetium-177 DOTA girentuximab | Phase 3 / Recruiting | Telix Pharmaceuticals Ltd. | Australia | Dose Optimization -safety and tolerability Through study completion, an average of 1.5 years | 2027-08-31 |
| NCT07187778 | Belzutifan | Phase 2 / Recruiting | The University of Texas MD Anderson Cancer Center | United States | 1. Safety and Adverse Events (AEs) Through study completion; an average of 1 year | 2027-07-19 |
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
NCT07160335 is a Phase 1, active, not recruiting study with 174 planned participants. Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment.
The primary endpoint is “AUC0-21d” over “rom time 0 to 21 days after the 1st dose (3 weeks).” The retrieved endpoint description is: Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose.
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 174 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Pembrolizumab, Pembrolizumab biosimilar(Henlius) 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
5 recent result records were selected as contextual evidence for Renal Cell Carcinoma. These records do not establish direct evidence for NCT07160335 unless the registration number matches.
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cel…
Phase 3; n=681; Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean): Adjusted Geometric Mean Ratio = 2.098(90% CI, 2.001 - 2.200); Adjusted Geometric Mean Ratio = 0.999(90% CI, 0.915 - 1.090); Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean) = 75.504 μg/mL (90% Confidence Interval, 70.941 - 80.361) Source: https://clinicaltrials.gov/ct2/show/results/NCT04810078
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Phase 2; n=10; ORR = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03274258
High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma
Phase 2; n=6; ORR = 1 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03991130
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
Pembrolizumab biosimilar(Henlius) is indexed as Biosimilar with PD-1 biology and a global stage of Phase 3. The asset profile lists Shanghai Henlius Biotech, Inc. as an originator or developer.
Shanghai Henlius Biotech, Inc. is indexed in China with the website http://www.henlius.com. Shanghai Henlius Biotech is joint venture company that provides clinical-stage biopharmaceutical services. The record lists 79 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 Pembrolizumab biosimilar(Henlius) 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: NCT07160335
Protocol source: https://clinicaltrials.gov/study/NCT07160335
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.
Pembrolizumab biosimilar(Henlius) in Renal Cell Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes AUC0-21d and 2027-04-30 the leading decision points.
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