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

ConditionsNon-small Cell Lung CancerMelanomaRenal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Henlius Biotech

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines.

At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF.

18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg.

NSCLC patients after complete resection OR

Disqualifiers

Pregnant or lactating women.

History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.

Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma)； known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R).

Participants with MEL have mucosal or ocular melanoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX17

    Drug

    Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle

  • US-sourced Keytruda®

    Drug

    Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: HLX17Experimental treatment 1 intervention
Group B: US-sourced Keytruda®Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

AUC0-21d

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose

Time frame
rom time 0 to 21 days after the 1st dose (3 weeks)
2

AUCss

Area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the 6th dose

Time frame
from time 0 to 21 days after the 6th dose (18 weeks)

Secondary outcomes

1

maximum serum drug concentration (Cmax),

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Time frame
up to 24 weeks
2

trough serum drug concentration at steady state (Ctrough,ss)

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Time frame
up to 24 weeks
3

maximum serum drug concentration at steady state (Cmax,ss)

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Time frame
up to 24 weeks
4

trough serum drug concentration (Ctrough)

Detailed Outcome Measure will be defined in the Statistical Analysis Plan

Time frame
up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov
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