OncoMatch/Clinical Trials/NCT06758557
A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor
Is NCT06758557 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including HB0025 and Pemetrexed for advanced nsclc.
Treatment: HB0025 · Pemetrexed · Paclitaxel · Carboplatin — This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib/II clinical trial of HB0025 combined with chemotherapy, consists of two phases: the dose escalation phase (Ib) and the dose expansion phase (II). 1. The dose escalation phase (Phase Ⅰb) The primary purpose is to determine the Maximum Tolerated Dose(MTD) and/or dose limiting toxicity (DLT) of HB0025 combined with chemotherapy. The dose escalation is carried out using the "3+3 dose escalation" principle. In the initial stage of the dose escalation process, the chemotherapy dose remains unchanged to explore the safety and tolerability of the currently confirmed safe doses of HB0025 as monotherapy at 10mg/kg, and 20mg/kg, combined with chemotherapy(Pemetrexed 500 mg/m² iv d1+Carboplatin AUC 5 iv d1) in the treatment of advanced non-squamous non-samll cell lung cancer(Non-sq-NSCLC), and combined with chemotherapy( Paclitaxel 175 mg/m² iv d1+ Carboplatin AUC 5 iv d1 ) in advance Endometrial carcinoma(EC). After completing the first cycle of treatment (DLT evaluation period), if the investigator determines that the subject may benefit from the combined treatment, the subject will continue the treatment cycles (2nd to 4th/5th/6th cycle of HB0025 combined with chemotherapy); if there is no disease progression and no intolerable toxicity, the subject can continue to receive the maintenance treatment with HB0025 + pemetrexed (for non-sq NSCLC) or HB0025 alone (for EC, sq NSCLC), until when intolerable toxicity occurs, disease progression, the subject is lost to follow-up or died, the subject withdraws informed consent, the subject receives other anti-tumor treatment or the study is terminated early, whichever occurs first. 2. Dose expansion phase (Phase II) Based on 1-2 recommended Phase II doses selected by the sponsor and the investigator during the dose escalation process, a multicenter, single-arm study will be conducted to evaluate the efficacy and safety of different doses of HB0025 combined with chemotherapy. Each dosing regimen cohort will be expanded by 40 subjects. If a dosing regimen is not safe or effective, the enrollment of the dosing regimen cohort may be stopped, and the subject quota may be allocated to other dosing regimen cohorts (which may exceed 40 subjects). The dose expansion phase initially plans to expand the following cohorts to further observe the safety of HB0025 combined with chemotherapy and the preliminary efficacy of HB0025 combined with chemotherapy in advanced NSCLC and EC. After receiving 4-6 cycles of HB0025 combined with chemotherapy, the subjects will enter HB0025 + pemetrexed (for non-sq-NSCLC) or HB0025 alone (for EC, sq-NSCLC) maintenance treatment until when intolerable toxicity, disease progression or death occurs, withdraw informed consent, or receives other anti-tumor treatment or study ends early, early, whichever occurs first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Endometrial Cancer
Biomarker criteria
Required: ALK wild-type
Required: BRAF wild-type
Required: EGFR wild-type
Required: NTRK1 wild-type
Required: NTRK2 wild-type
Required: NTRK3 wild-type
Required: RET wild-type
Required: ROS1 wild-type
Allowed: ALK translocation
Allowed: EGFR tki drug sensitivity mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor treatment
Exception: adjuvant/neoadjuvant therapy for non-metastatic disease with curative intent allowed if progression >6 months after last treatment
No previous systemic anti-tumor treatment (for subjects who have received adjuvant/neoadjuvant treatment for non-metastatic disease with the purpose of cure, if disease progression occurs within 6 months of the end of the last treatment, the treatment regimen is considered as one systemic treatment and is not allowed to be included)
Cannot have received: immune checkpoint inhibitor combined with anti-vascular therapy (anti-PD-(L)-1 antibody combined with anti-VEGF, VEGFR antibody, TKI drugs with anti-vascular effects such as anlotinib)
Patients who have received immune checkpoint inhibitors (ICI) combined with anti-vascular therapy, such as anti-PD-(L)-1 antibody combined with anti-VEGF, VEGFR antibody, or TKI drugs with anti-vascular effects such as anlotinib
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥90×10⁹/L; Hemoglobin ≥90 g/L; no blood component or cell growth factor support therapy within two weeks before blood collection
Kidney function
Creatinine clearance ≥50 mL/min (Cockcroft-Gault Formula)
Liver function
Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN (≤5×ULN if due to liver metastasis)
9.1 Absolute neutrophil count ≥1.5×10⁹/L; 9.2 Platelet count ≥90×10⁹/L; 9.3 Hemoglobin ≥90 g/L; 9.4 Creatinine clearance ≥50 mL/min (Cockcroft-Gault Formula); 9.5 Total bilirubin ≤1.5×ULN; 9.6 AST and ALT ≤2.5×ULN; ≤5×ULN if due to liver metastasis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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