US-sourced Keytruda® / HLX17 / Melanoma · Phase 1 Trial

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registration for a Phase 1 biosimilar comparability study of HLX17 (a pembrolizumab biosimilar candidate) versus US-sourced Keytruda® in patients with resected NSCLC, melanoma, or RCC. No results have been posted in this registry record; the study is in active recruitment or recently closed to enrollment.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma; age from 18 Years; to 85 Years. Intervention: HLX17. Compared with: US-sourced Keytruda® — Active Comparator. n = 174. 69 sites across 4 countries.

Key findings

Safety

This is a registry record with no posted results; no efficacy, safety, or immunogenicity outcomes are reported. Phase 1 studies are designed for dose-finding and safety; efficacy claims cannot be drawn.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 study registration with no posted results; designed to evaluate PK similarity and safety of a biosimilar candidate versus reference comparator in early-stage oncology patients.

Study design

As stated by the source record.

MethodsPrimary outcome measures: AUC0-21d (assessed at rom time 0 to 21 days after the 1st dose (3 weeks)); AUCss (assessed at from time 0 to 21 days after the 6th dose (18 weeks))

DesignPhase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationNon-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma; age from 18 Years; to 85 Years

Sample size174

InterventionHLX17

ComparatorUS-sourced Keytruda® — Active Comparator

Setting69 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment174

Study phasePhase 1

Primary outcome measure 1AUC0-21d from time 0 to 21 days after 1st dose

Primary outcome measure 2AUCss from time 0 to 21 days after 6th dose

Caveats

This is a registry record with no posted results; no efficacy, safety, or immunogenicity outcomes are reported.
Phase 1 studies are designed for dose-finding and safety; efficacy claims cannot be drawn.
Recruitment status is ACTIVE_NOT_RECRUITING, indicating study is closed to new enrollment but may not be complete.
Primary endpoints are pharmacokinetic; clinical efficacy outcomes are not yet assessed or reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Multicenter, randomized, double-blind, parallel-controlled Phase 1 design.

Directness

moderate

PK and safety endpoints in resected solid tumors; efficacy and immunogenicity also stated.

Consistency

insufficient

Registry record only; no results or comparison data reported.

Risk of bias

moderate

Double-blind design reduces bias; Phase 1 early-stage work limits scope.

Sample adequacy

limited

Estimated 174 participants planned; Phase 1 typically underpowered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07160335). This is a study registration, not published results. Lead sponsor: Shanghai Henlius Biotech. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 174 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma. Interventions: DRUG: HLX17; DRUG: US-sourced Keytruda®. Primary outcome measures: AUC0-21d , rom time 0 to 21 days after the 1st dose (3 weeks); AUCss , from time 0 to 21 days after the 6th dose (18 weeks). Brief summary: This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

US-sourced Keytruda®HLX17Shanghai Henlius BiotechMelanomaRenal Cell CarcinomaNCT07160335Non Small Cell Lung Cancer