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

NCT07419880 | Not Yet Recruiting Phase 2

• 1 other identifier: SCHBCC-N0106
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Triple -Negative Breast Cancer

Keywords

TNBC; Molecular Subtype; Precision Treatment; Immunotherapy; Cromolyn; Antibody-Drug Conjugate

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

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

  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 (3)

• Disease Control Rate(DCR)

  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

• Progression Free Survival(PFS)

  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

• Overall Survival (OS)

  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

  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

Study Arms (1)

Cromolyn plus TQB2102and Panpulimab

EXPERIMENTAL

Cromolyn：a mast cell membrane stabilizer；TQB2102: HER2-ADC； Panpulimab: anti PD-1

Drug: Cromolyn, TQB2102, and Panpulimab

Interventions

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).

Cromolyn plus TQB2102and Panpulimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Organ Function: Adequate organ function as follows:
• Blood Counts: Hemoglobin ≥90 g/L (no transfusion within 14 days); absolute neutrophil count ≥1.5×10⁹/L; platelets ≥75×10⁹/L.
• Blood Chemistry: Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN (≤5×ULN if liver metastases are present); serum creatinine ≤1×ULN; creatinine clearance \>50 mL/min (Cockcroft-Gault formula).
• Treatment-Free Interval: No radiotherapy, endocrine therapy, molecular targeted therapy, or major surgery within 3 weeks prior to study entry; recovery from prior treatment-related toxicities (surgical wounds fully healed if applicable); absence of peripheral neuropathy or only grade I peripheral neuropathy.
• Performance Status: ECOG performance status ≤1, and life expectancy ≥3 months.
• Contraception: Women of childbearing potential must agree to use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
• Consent: Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.

You may not qualify if:

• 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.
• Recent Major Surgery: Undergone major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment.
• Pregnancy or Lactation: Patients who are pregnant or breastfeeding.
• Other Malignancies: History of other malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
• Impaired Drug Absorption: Conditions affecting oral drug intake and absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction.
• Uncontrolled Effusions: Uncontrolled third-space effusions (e.g., significant pleural or ascitic fluid) not manageable by drainage or other methods.
• Non-Healing Conditions: Long-term non-healing wounds or incompletely healed fractures.
• Active Viral Hepatitis: Active HBV or HCV infection (HBV-DNA ≥ 500 IU/mL) or chronic hepatitis with abnormal liver function.
• Allergic History: Known allergy or hypersensitivity to any component of the study regimen, or history of hypersensitivity to other monoclonal antibodies.
• Eosinophilia/Mastocytosis: Patients with eosinophilia or mastocytosis.
• Steroid Use: Chronic use of oral corticosteroids. Occasional past use requires a 4-week washout period before enrollment.
• Prior Use of Specific Therapies: Previous treatment with PD-1/TGF-β bispecific antibody, PD-1/CTLA-4 bispecific antibody, PD-1/VEGF bispecific antibody, or anti-HER2 dual-epitope ADC; or use of ADC agents in ≥2 prior lines of therapy.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhimin Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao

CONTACT

+88807 08664175590; zhimingshao@yahoo.com

Zhonghua Wang

CONTACT

+88807 08664175590; zhonghuawang95@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 19, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

CN (1)