OncoMatch/Clinical Trials/NCT07160335
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
Is NCT07160335 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including HLX17 and US-sourced Keytruda® for non-small cell lung cancer.
Treatment: HLX17 · US-sourced Keytruda® — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Melanoma
Renal Cell Carcinoma
Biomarker criteria
Required: EGFR sensitizing mutation
known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R)
Required: EGFR wild-type
known positive for EGFR sensitive mutations ... [excluded]
Required: ALK fusion
known positive for ... ALK fusion [excluded]
Performance status
ECOG 0–0(Fully active)
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor (pembrolizumab)
Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before randomization
Cannot have received: organ or bone marrow transplantation
Have received an organ or bone marrow transplantation prior to randomization or scheduled for transplantation during the study
Lab requirements
Blood counts
adequate organ function as indicated by laboratory values
Kidney function
adequate organ function as indicated by laboratory values
Liver function
adequate organ function as indicated by laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose)
adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Oncology Physicians Network (OPN) - Glendale · Glendale, California
- Oncology Physicians Network (OPN)- Los Alamitos · Los Alamitos, California
- HCA · Los Angeles, California
- Los Angeles Cancer Network · Los Angeles, California
- Oncology Physicians Network (OPN) - San Bernardino · San Bernardino, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07160335 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, organ or bone marrow transplantation disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify