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

Part of paid clinical trials in Glendale, California.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07160335
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Sep 26, 2025
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Mar 27, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX17
    Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle, until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).
  • Active Comparator: US-sourced Keytruda®
    Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle, for a total of 8 cycles (24 weeks). After 8 cycles, all subjects in the US-sourced Keytruda® group will receive HLX17 200 mg on Day 1 of each 3-week cycle until 12 months after the randomization (nearly 17 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first).

Primary Outcome Measure

AUC0-21d [ Time Frame: rom time 0 to 21 days after the 1st dose (3 weeks) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Oncology Physicians Network (OPN) - GlendaleGlendaleCalifornia91203
David Palchak
Oncology Physicians Network (OPN)- Los AlamitosLos AlamitosCalifornia90720
Vu Phan
818-254-2526
HCALos AngelesCalifornia64132
Joseph Stilwill
913-498-7409
Los Angeles Cancer NetworkLos AngelesCalifornia92801
Sungwon Kyung
[email protected]
Oncology Physicians Network (OPN) - San BernardinoSan BernardinoCalifornia91203
Walter Tsang
BRCR GlobalDeerfield BeachFlorida33326
Sumit Sawhney
561-447-0614
D&H National Research CenterMargateFlorida33063
Emilio Araujo
954-323-2422
Ocala OncologyOcalaFlorida34474
Anju Vasudevan
352-732-4938
Mid Florida Hematology and oncology CenterOrange CityFlorida32763
Santosh Nair
386-774-1223
Oncology Consulatants (P1 Trials -Exigent Network)HoustonTexas77030
Julio Peguero
713-600-0900
American Oncology Network Vista Oncology DivisionOlympiaWashington98506
Joseph Ye
360-413-8880
Northwest Medical Specialties PPLC (P1 Trials - Exigent Network )TacomaWashington98405
Jorge Chaves
253-380-8173

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Oncology Physicians Network (OPN) - Glendale· Glendale, CAOncology Physicians Network (OPN)- Los Alamitos· Los Alamitos, CAHCA· Los Angeles, CALos Angeles Cancer Network· Los Angeles, CAOncology Physicians Network (OPN) - San Bernardino· San Bernardino, CABRCR Global· Deerfield Beach, FL

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