A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors

NCT06413615 | Recruiting Phase 2

• 1 other identifier: F0034-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1

  up to 24 month

• Occurrence of adverse events (AEs) and serious adverse events (SAEs)

  Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.

  up to 24 month

Secondary Outcomes (9)

• Duration of response (DoR)

  up to 24 month

• Disease control rate (DCR)

  up to 24 month

• Progression free survival (PFS)

  up to 24 month

• Overall survival (OS)

  up to 24 month

• Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum FDA022-BB05 Following First Dose

  From cycle1 to Cycle10 (each cycle is 21 days. )

Study Arms (3)

HER2 Low Metastatic/Recurrent Breast Cancer

EXPERIMENTAL

Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

Drug: FDA022-BB05

HER2 Expressing Metastatic/Recurrent Endometrial Cancer

EXPERIMENTAL

Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

Drug: FDA022-BB05

HER2 Overexpressing/Mutant Metastatic/Recurrent Solid tumor

EXPERIMENTAL

Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

Drug: FDA022-BB05

Interventions

FDA022-BB05 DRUG

Monoclonal antibody-drug conjugate for injection

HER2 Expressing Metastatic/Recurrent Endometrial Cancer; HER2 Low Metastatic/Recurrent Breast Cancer; HER2 Overexpressing/Mutant Metastatic/Recurrent Solid tumor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fully understand and voluntarily participate in this study and sign informed consent.
• Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose.
• Eastern Cooperative Oncology Group performance status( PS) of 0 or 1. Life expectancy ≥ 3 months.
• Histopathologically or cytologically confirmed advanced/unresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available:
• Cohort A: Pathologically documented breast cancer that:
• Is unresectable or metastatic.
• Has a history of low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
• For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.
• Was never previously HER2-positive(IHC 3+ or IHC 2+/ISH+) on prior pathology testing or was historically HER2 IHC 0 only.
• Cohort B: Pathologically documented endometrial cancer that:
• Is unresectable or metastatic.
• Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC).
• Have had at least one prior line of platinum-based therapy (in any setting).
• Was never previously received other ADC anti-tumor treatment.
• Cohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer).

You may not qualify if:

• A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.
• Subjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months.
• Subjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment).
• Subjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy.
• Adverse reactions from the previous anti-tumor treatment have not yet recovered (\>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator).
• Subjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:
• a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
• a medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females.
• Subjects with a medical history of interstitial lung disease (ILD)/pneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening.
• Subjects with any uncontrolled active infection within 1 week prior to first dose.
• Subjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB05.
• Subjects with a History of alcohol abuse or psychotropic/narcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons.

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Study Officials

• Jian Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang, MD

CONTACT

021-64175590; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: May 13, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)