A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib; Drug: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia

• Registration Number: NCT05564858
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Brief Summary

This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.

Detailed Description

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FDA022-BB05 in patients with advanced/metastatic solid tumors. FDA022-BB05 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify dose-limiting toxicities（DLT）and the maximum tolerated dose (MTD) through Day1 and Day 21 (cycle 1) with 1 dose. In addition, the recommended Phase II dose of FDA022-BB05 will be determined.

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Study Start: 2023-01-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase Ib Dose expansion	FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib	Phase Ib: is a dose expansion to examine the safety and efficacy of FDA022-BB05 and it is consist of multiple cohorts: in subjects with HER2 overexpressing breast cancer (Cohort A); HER2 overexpressing gastric or gastroesophageal junction adenocarcinoma (Cohort B).
Phase Ia Dose escalation	FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia	Phase Ia: Participants with locally advanced or metastatic tumor will be administered FDA022-BB05 intravenously once at escalated doses in each cycle (of 21 days) during Phase Ia part of the study until disease progression or intolerable toxicity.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Cycle 1 (21Days)	DLT will be assessed according to NCICTCAE v5.0.
Maximum tolerated dose (MTD）	Cycle 1 (21 Days)	MTD will be defined as the maximum dose level at which no more than 1 of 3 patients experience a DLT within cycle1 (21 days) of DLT observing period.
RP2D	Cycle1 (21 Days)	the recommended phase II dose
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)	Up to 3 years	The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) characteristics, CL/F	From cycle1 to Cycle10 (each cycle is 21 days. )	apparent Clearance
Pharmacokinetic (PK) characteristics，AUC	From cycle1 to Cycle10 (each cycle is 21 days. )	Area under the plasma concentration versus time curve
ADA	Up to 18 months	Anti-drug antibody
DoR	Up to 18 months	Duration of response
OS	Up to 3 years	Overall survival rate
Pharmacokinetic (PK) characteristics, Cmax	From cycle1 to Cycle10 (each cycle is 21 days. )	Peak Plasma Concentration
Pharmacokinetic (PK) characteristics, Tmax	From cycle1 to Cycle10 (each cycle is 21 days. )	Time of peak plasma concentration
Pharmacokinetic (PK) characteristics, t1/2	From cycle1 to Cycle10 (each cycle is 21 days. )	Half-life time
ORR	Up to 18 months	Objective Response Rate
PFS	Up to 18 months	Progression-free survival

Trial Locations

Locations (1)

Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China