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Advanced Solid TumorsPhase 1NCT05564858

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

A Phase 1 study testing FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia and FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib in people with Advanced Solid Tumors, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia and FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteChina
Study dates
16 Jan 2023to Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • During the screening period, the patients should meet the following requirements: Absolute value of neutrophils ≥ 1.5 × 109/L, Platelet ≥ 100 × 109/L, Hemoglobin ≥ 90 g/L (no blood transfusions and no use of CSF in 2 weeks); The internationally standardized ratio (INR), prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5 × ULN; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × ULN, AST/ALT ≤ 5 × ULN for liver metastasis; Serum creatinine≤ 1.5×ULN，or Ccr ≥60 mL/min calculated by Cockcroft and Gault formula;
  • Preferential subjects with measurable lesion in Part 1. and subjects with at least one measurable lesion in Part 2;
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  • All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0 ≤ 1;
  • Eligible fertile female participants or male participants with fertile female sexual partners must agree to use an effective method of contraception from the study initiation until at least 6 months after the last treatment; Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
  • 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 in Part 1;
  • Pathologically confirmed advanced/unresectable or metastatic breast cancer with HER2 overexpression that failed with one or more prior HER2 targeted therapy in Cohort A of Part 2;
  • Pathologically confirmed advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that failed with two or more prior HER2 targeted therapy in Cohort B of Part 2.

Who cannot join

  • 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.
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  • 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 positive human immunodeficiency virus (HIV) antibody, active hepatitis C (antibody positive with HCV RNA positive), active hepatitis B (positive hepatitis B virus surface antigen with HBV-DNA titer higher than the upper limit of the reference range);
  • 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.

Trial locations and contacts

1 site in 1 country.

Xinghe Wang contact

+86 01063926401

wangxh@bjsjth.cn

China1 site, 1 recruiting

  • Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038

    Xinghe Wang, +86 01063926401, wangxh@bjsjth.cn

    Recruiting

Other trials in China

About this study

Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

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.

Read the 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.

Being tested
FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia, FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib
Keywords
Advanced solid tumors, phase 1, oncology, HER2, Antibody drug conjugate (ADC)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDA022 Monoclonal antibody-drug conjugate for injection Phase IaDrug

    Also called FDA022-BB05

    FDA022-BB05, intravenously infusion, q3w

  • FDA022 Monoclonal antibody-drug conjugate for injection Phase IbDrug

    Also called FDA022-BB05

    FDA022-BB05, intravenously infusion, q3w

Study groups in NCT05564858
Study groupRoleWhat they receive
Phase Ia Dose escalationExperimentalPhase 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.
Receives: Drug: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia
Phase Ib Dose expansionExperimentalPhase 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).
Receives: Drug: FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    DLT will be assessed according to NCICTCAE v5.0.

    Measured: Cycle 1 (21Days)

  2. Maximum tolerated dose (MTD）

    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.

    Measured: Cycle 1 (21 Days)

  3. Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs)

    The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Up to 3 years

  4. RP2D

    the recommended phase II dose

    Measured: Cycle1 (21 Days)

Secondary outcomes (10)

  1. Pharmacokinetic (PK) characteristics, Cmax

    Peak Plasma Concentration

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

  2. Pharmacokinetic (PK) characteristics, Tmax

    Time of peak plasma concentration

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

  3. Pharmacokinetic (PK) characteristics，AUC

    Area under the plasma concentration versus time curve

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

  4. Pharmacokinetic (PK) characteristics, t1/2

    Half-life time

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

  5. Pharmacokinetic (PK) characteristics, CL/F

    apparent Clearance

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

  6. ADA

    Anti-drug antibody

    Measured: Up to 18 months

  7. ORR

    Objective Response Rate

    Measured: Up to 18 months

  8. PFS

    Progression-free survival

    Measured: Up to 18 months

  9. DoR

    Duration of response

    Measured: Up to 18 months

  10. OS

    Overall survival rate

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start16 Jan 2023
  3. Primary completionSep 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
107 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564858
Sponsor's protocol ID
F0034-101
Status last verified
May 2024
First submitted
20 Sep 2022
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia and FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib in people with Advanced Solid Tumors, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xinghe Wang (+86 01063926401, wangxh@bjsjth.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Cycle 1 (21Days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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