NCT04802980

A Study of HB002.1T Plus Chemotherapy in Subjects With Solid Tumor

A Phase Ib, Multicenter, Open-label, Dose-escalation and Dose-expansion Study of the Safety, Tolerability and Pharmacokinetics of HB002.1T in Combination With Chemotherapy in Patients With Advanced Solid Tumors.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Huabo Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.

Detailed description

This study is a Phase1b, multicenter, open-label, dose-escalation and dose-expansion in selected solid tumor indications. There are two parts to this study: a dose-escalation part and a dose-expansion part. About 63-72 subjects is planned to recruit, 27\~36 subjects (9\~12 subjects each arm) will be recruited during dose-escalation period The sample size may vary depending on the DLT observed at each dose level. The conventional 3+3 design will be applied for dose escalation. This trial will evaluate two adaptive dose levels, 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs). Cohorts of 3 subjects with metastatic or locally advanced solid tumors will receive HB002.1T at escalating dose levels in combination with different chemotherapy regimens. After determination of the Maximum tolerated dose (MTD), another 12 patients in each of 3 cohorts will be added to determine the safety, tolerability, pharmacokinetic (PK), and clinical activity of HB002.1T.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HB002.1T	HB002.1T is a vascular endothelial growth factor receptor decoy
DRUG	Oxaliplatin	Oxaliplatin is an anti-tumor drug
DRUG	Capecitabine	Capecitabine is an anti-tumor drug
DRUG	Paclitaxel	Paclitaxel is an anti-tumor drug
DRUG	Gemcitabine	Gemcitabine is an anti-tumor drug
DRUG	Cisplatin	Cisplatin is an anti-tumor drug
DRUG	Carboplatin	Carboplatin is an anti-tumor drug

Timeline

• Start date: 2020-04-28
• Primary completion: 2023-07-15
• Completion: 2023-09-01
• First posted: 2021-03-17
• Last updated: 2021-07-28

Locations

1 site across 1 country: China