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A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases

ConditionMetastatic Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Syncor Pharmaceutical Co., Ltd.

About this trial

A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age should be up to 18 years at the time of signing the informed consent form (ICF);

The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;

The expected survival period should be ≥ 3 months

Phase I and phase II: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment

Disqualifiers

The washout period before the first administration of the study drug was insufficient.

Previous received similar radionuclide internal irradiation treatment.

Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.

Known "super bone imaging".

Trial design

Design model

Sequential

Treatments tested in this trial

  • BPR-6023021 for injection

    Drug

    BPR-6023021 is a Radionuclide conjugated drugs (RDC) targeting bone.

Treatment groups

195 Participants
are divided into 2 treatment groups
Group A: Phase 1:Dose escalationExperimental treatment 1 intervention
Group B: Phase 2: RP2D CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
Up to 1 year

Secondary outcomes

1

Dosimetry，including Maximum plasma concentration (Cmax) of BPR-6023021

To collect the biological distribution of major tissues/organs and so on.

Time frame
Through study completion, an average of 2 year
2

Time to Radiographic Bone Progresion (TTRBP)

Time from start of treatment to progression of bone lesion (PD) or death, whichever occurs first, during the study period

Time frame
Through study completion, an average of 2 year
3

Radiographic progression-free survival (rPFS)

Time from start of treatment to progression of Disease (PD) or death, whichever occurs first

Time frame
Through study completion, an average of 2 year
4

Symptomatic skeletal event-free survival (SSE-FS)

Time from start of treatment to the first occurrence of new SSE or death from any cause , whichever occurs first.

Time frame
Through study completion, an average of 2 year

Other outcomes

Sponsors and contacts

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

Chengdu Syncor Pharmaceutical Co., Ltd.

Lead sponsor

Beijing Quarkxia Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: