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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects fully understand and voluntarily participate in this study and sign informed consent.

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.

Disqualifiers

A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FDA022-BB05

    Drug

    Monoclonal antibody-drug conjugate for injection

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: HER2 Low Metastatic/Recurrent Breast CancerExperimental treatment 1 intervention
Group B: HER2 Expressing Metastatic/Recurrent Endometrial CancerExperimental treatment 1 intervention
Group C: HER2 Overexpressing/Mutant Metastatic/Recurrent Solid tumorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

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

Time frame
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.

Time frame
up to 24 month

Secondary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
up to 24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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