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Advanced Solid TumorPhase 2NCT06413615

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

A Phase 2 study testing FDA022-BB05 in people with Advanced Solid Tumor, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
FDA022-BB05
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
13 May 2024to 30 Jun 2026
Phase
Phase 2
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.
  • 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.
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  • 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).

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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

Jian Zhang, MD contact

021-64175590 ext. 85000

syner2000@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Jian Zhang, MD, 021-64175590 ext. 85000, syner2000@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients with Advanced/Metastatic Solid Tumors

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.

Being tested
FDA022-BB05

What participants receive

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

  • FDA022-BB05Drug

    Monoclonal antibody-drug conjugate for injection

Study groups in NCT06413615
Study groupRoleWhat they receive
HER2 Low Metastatic/Recurrent Breast CancerExperimentalEnrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
Receives: Drug: FDA022-BB05
HER2 Expressing Metastatic/Recurrent Endometrial CancerExperimentalEnrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
Receives: Drug: FDA022-BB05
HER2 Overexpressing/Mutant Metastatic/Recurrent Solid tumorExperimentalEnrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
Receives: Drug: FDA022-BB05

What is being measured

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

  1. Objective Response Rate (ORR)

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

    Measured: up to 24 month

  2. Occurrence of adverse events (AEs) and serious adverse events (SAEs)

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

    Measured: up to 24 month

Secondary outcomes (9)

  1. Duration of response (DoR)

    DOR is defined as the time from the date of first documented response until the date of documented progression or death.

    Measured: up to 24 month

  2. Disease control rate (DCR)

    DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).

    Measured: up to 24 month

  3. Progression free survival (PFS)

    PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.

    Measured: up to 24 month

  4. Overall survival (OS)

    OS is the time from date of first dose of study treatment until death due to any cause.

    Measured: up to 24 month

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

    The serum PK parameters of FDA022-BB05 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.

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

  6. Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum FDA022-BB05 Following First Dose

    The serum PK parameters Maximum (peak) Observed serum concentration of FDA022-BB05 and its analytes were estimated using standard non-compartmental method.

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

  7. Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum FDA022-BB05 Following First Dose

    The serum PK parameters of Time of maximum plasma concentration (Tmax) for FDA022-BB05 and its analytes were estimated using standard non-compartmental methods.

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

  8. Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum FDA022-BB05 Following First Dose

    The serum PK parameters of Terminal elimination half-life for FDA022-BB05 and its analytes was estimated using standard non-compartmental methods.

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

  9. Number of participants who developed measurable anti-drug antibodies

    Individual participant data and descriptive statistics will be provided for data at each time point.

    Measured: up to 24 month

Timeline

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

  1. First posted14 May 2024
  2. Study start13 May 2024
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion30 Jun 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413615
Sponsor's protocol ID
F0034-201
Status last verified
Apr 2024
First submitted
8 May 2024
Last updated
26 Sep 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 2 study testing FDA022-BB05 in people with Advanced Solid Tumor, 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 15 inclusion and 12 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 26 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jian Zhang, MD (021-64175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 24 month). The study lists 2 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 NCT06413615.

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 26 Sep 2024.

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