A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

NCT06202261 | Recruiting Phase 1

• 1 other identifier: TQB2930-Ib/II-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).

Conditions

Metastatic Breast Cancer; Recurrent Breast Cancer; Advanced Malignancies

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.

  Baseline up to 4 months

• Phase II recommended dose (P2RD)

  Optimal tolerated dose determined after the end of phase 1

  Baseline up to 1 year

• Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

  The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.

  Baseline up to 2 year

Secondary Outcomes (12)

• Immunogenicity

  Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.

• Peak concentration (Cmax), QW

  Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.

• Peak concentration (Cmax), Q2W

  Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.

• Peak concentration (Cmax), Q3W

  Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.

• Overall survival (OS)

  Baseline up to 4 years

Study Arms (4)

TQB2930 for injection

EXPERIMENTAL

TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle.

Drug: TQB2930 for injection

TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)

EXPERIMENTAL

TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle

Drug: TQB2930 for injection; Drug: Paclitaxel for injection (albumin-bound)

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

EXPERIMENTAL

TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle.

Drug: TQB2930 for injection; Drug: TQB3616 capsule; Drug: Fulvestrant injection

TQB2930 for injection + chemotherapy

EXPERIMENTAL

TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle.

Drug: TQB2930 for injection; Drug: Capecitabine tablets; Drug: Vinorelbine tartrate injection; Drug: Eribulin mesylate injection; Drug: gemcitabine hydrochloride for injection

Interventions

TQB2930 for injection DRUG

TQB2930 for injection is a HER2 bispecific antibody.

TQB2930 for injection; TQB2930 for injection + chemotherapy; TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound); TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Paclitaxel for injection (albumin-bound) DRUG

It is an anti-microtubule chemotherapy drug

TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)

TQB3616 capsule DRUG

TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Fulvestrant injection DRUG

Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol

TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection

Capecitabine tablets DRUG

Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.

TQB2930 for injection + chemotherapy

Vinorelbine tartrate injection DRUG

Vinorelbine is an anti-tumor drug of vinca alkaloids.

TQB2930 for injection + chemotherapy

Eribulin mesylate injection DRUG

Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.

TQB2930 for injection + chemotherapy

gemcitabine hydrochloride for injection DRUG

Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

TQB2930 for injection + chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months.
• Phase Ib
• Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
• Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
• Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
• Phase II
• Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:
• Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
• at least one measurable lesion that meets the RECIST 1.1 criteria.
• Major organs are functioning normally.
• Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.

You may not qualify if:

• Have occured other malignant tumors within 3 years prior to first dose.
• Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
• Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
• Long-term unhealed wounds or fractures;
• Arterial/venous thrombosis events occurred within 6 months before the first dose;
• Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;
• Subject with any severe and/or uncontrolled disease;
• Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;
• Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;
• Severe bone injury due to bone metastasis;
• Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;
• In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \<50% or absolute LVEF decreased \>15%;
• Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \>360 mg/m2;
• Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy
• Patients with severe hypersensitivity after the use of monoclonal antibodies;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Affiliated cancer hospital of harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections; Paclitaxel; Fulvestrant; Capecitabine; Vinorelbine; eribulin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Qingyuan Zhang, Doctor

CONTACT

+86 0451 86298070; sy86298276@163.com

Xiaohua Zeng, Doctor

CONTACT

13983687701; zengxiaohua000017@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: April 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (2)