Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-27 @ 10:22 PM
Study NCT ID:
NCT06758557
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor
Sponsor:
Huabo Biopharm Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Open Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HB0025 Injection Combined With Chemotherapy in Patients With Advanced Solid Tumor
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
The design of dose level and Cohorts:
Phase Ib:
Advanced Non-sq-NSCLC(dose escalation phase):
The dose level of HB0025 including the following leves, the dose of chemotherapy is fixed(Pemetrexed 500 mg/m² iv d1+Carboplatin AUC 5 iv d1) in the study.
dose 1: 10mg/kg, dose 2: 20mg/kg, dose -1: 6mg/kg, dose +1: 15mg/kg, dose +2: 30mg/kg.
Advanced EC and sq-NSCLC:
With the same dose level design above, HB0025 combined with Paclitaxel(175 mg/m² iv d1) and Carboplatin(AUC 5 iv d1) in the treatment of advanced EC and sq-NSCLC.
Phase II:
Advanced non-small cell lung cancer indications:
1. Cohort 1: Patients with recurrent, metastatic, locally advanced non-squamous non-small cell lung cancer (Non-sq-NSCLC) who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 10mg/kg combined with Pemetrexed 500 mg/m² iv d1 + Carboplatin AUC 5 iv d1; expended to approximately 40 subjects.
2. Cohort 2: Patients with recurrent, metastatic, locally advanced Non-sq-NSCLC who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 20mg/kg combined with the same dose as cohort 1; expended to approximately 40 subjects.
3. Cohort 3: Patients with recurrent, metastatic, locally advanced squamous non-small cell lung cancer (Sq-NSCLC) who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 10mg/kg combined with Paclitaxel 175mg/m² iv d1 + Carboplatin AUC 5 iv d1; expanded to approximately 40 subjects.
4. Cohort 4: Patients with recurrent, metastatic, locally advanced Sq-NSCLC who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 20 mg/kg combined with the same dose as Cohort 3; extended to approximately 40 subjects.
Advanced endometrial cancer indications:
1. Cohort 1: Patients with recurrent, metastatic, locally advanced endometrial cancer who have not received systemic anti-tumor treatment before; HB0025 at 10 mg/kg combined with Paclitaxel 175 mg/m² iv d1 + Carboplatin AUC 5 iv d1; expanded to approximately 40 subjects.
2. Cohort 2: Patients with recurrent, metastatic, locally advanced endometrial cancer who have not received systemic anti-tumor treatment before; HB0025 at 20mg/kg combined with chemotherapy as the same dose as Chort1; expanded to approximately 40 cases.
Phase Ib:
Advanced Non-sq-NSCLC(dose escalation phase):
The dose level of HB0025 including the following leves, the dose of chemotherapy is fixed(Pemetrexed 500 mg/m² iv d1+Carboplatin AUC 5 iv d1) in the study.
dose 1: 10mg/kg, dose 2: 20mg/kg, dose -1: 6mg/kg, dose +1: 15mg/kg, dose +2: 30mg/kg.
Advanced EC and sq-NSCLC:
With the same dose level design above, HB0025 combined with Paclitaxel(175 mg/m² iv d1) and Carboplatin(AUC 5 iv d1) in the treatment of advanced EC and sq-NSCLC.
Phase II:
Advanced non-small cell lung cancer indications:
1. Cohort 1: Patients with recurrent, metastatic, locally advanced non-squamous non-small cell lung cancer (Non-sq-NSCLC) who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 10mg/kg combined with Pemetrexed 500 mg/m² iv d1 + Carboplatin AUC 5 iv d1; expended to approximately 40 subjects.
2. Cohort 2: Patients with recurrent, metastatic, locally advanced Non-sq-NSCLC who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 20mg/kg combined with the same dose as cohort 1; expended to approximately 40 subjects.
3. Cohort 3: Patients with recurrent, metastatic, locally advanced squamous non-small cell lung cancer (Sq-NSCLC) who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 10mg/kg combined with Paclitaxel 175mg/m² iv d1 + Carboplatin AUC 5 iv d1; expanded to approximately 40 subjects.
4. Cohort 4: Patients with recurrent, metastatic, locally advanced Sq-NSCLC who have not received systemic anti-tumor treatment and do not carry EGFR sensitive mutations or ALK fusion gene sensitive mutations; HB0025 at 20 mg/kg combined with the same dose as Cohort 3; extended to approximately 40 subjects.
Advanced endometrial cancer indications:
1. Cohort 1: Patients with recurrent, metastatic, locally advanced endometrial cancer who have not received systemic anti-tumor treatment before; HB0025 at 10 mg/kg combined with Paclitaxel 175 mg/m² iv d1 + Carboplatin AUC 5 iv d1; expanded to approximately 40 subjects.
2. Cohort 2: Patients with recurrent, metastatic, locally advanced endometrial cancer who have not received systemic anti-tumor treatment before; HB0025 at 20mg/kg combined with chemotherapy as the same dose as Chort1; expanded to approximately 40 cases.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: