Health TrialsbyHealthPanel

Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer

ConditionTriple -Negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: Female, ≥18 years old and ≤70 years old.

Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with <1% positive tumor cells; PR-negative with <1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH/CISH without amplification).

Prior Treatment: Recurrent or metastatic refractory breast cancer with disease progression after prior immunotherapy.

Measurable Disease: At least one measurable lesion per RECIST v1.1 (≥20 mm by conventional CT or ≥10 mm by spiral CT; lesion must not have been previously irradiated).

Disqualifiers

Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).

CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.

Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.

Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cromolyn, TQB2102, and Panpulimab

    Drug

    Upon enrollment, patients will receive intravenous administration of penpulimab (200 mg) and TQB2102 (6 mg/kg) every three weeks, along with intranasal delivery of cromolyn sodium (each dose 10 mg \[5 sprays per nostril, bilaterally\], four times daily, administered 30 minutes before meals and at bedtime).

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Cromolyn plus TQB2102and PanpulimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

Disease Control Rate(DCR)

Complete remission or partial remission or stable disease (according to RECIST1.1)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
2

Progression Free Survival(PFS)

Time to progressive disease (according to RECIST1.1)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
3

Overall Survival (OS)

Time to death due to any cause

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Other outcomes

1

Translational alalyses

HER2, PD-L1, and mast cell status will be measured in pre-treatment tissues. Plasma inflammatory molecules and peripheral immune cells will be measured in pre- and on-treatment blood.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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