Health TrialsbyHealthPanel

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

ConditionsMetastatic Breast CancerRecurrent Breast CancerAdvanced Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2930 for injection

    Drug

    TQB2930 for injection is a HER2 bispecific antibody.

  • Paclitaxel for injection (albumin-bound)

    Drug

    It is an anti-microtubule chemotherapy drug

  • TQB3616 capsule

    Drug

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

  • Fulvestrant injection

    Drug

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

  • Capecitabine tablets

    Drug

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

  • Vinorelbine tartrate injection

    Drug

    Vinorelbine is an anti-tumor drug of vinca alkaloids.

  • 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.

  • gemcitabine hydrochloride for injection

    Drug

    Gemcitabine is a cell cycle specific anti-metabolic anticancer agent

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: TQB2930 for injectionExperimental treatment 1 intervention
Group B: TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound)Experimental treatment 2 interventions
Group C: TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injectionExperimental treatment 3 interventions
Group D: TQB2930 for injection + chemotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD)

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

Time frame
Baseline up to 4 months
2

Phase II recommended dose (P2RD)

Optimal tolerated dose determined after the end of phase 1

Time frame
Baseline up to 1 year
3

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.

Time frame
Baseline up to 2 year

Secondary outcomes

1

Immunogenicity

Incidence of anti-drug antibody (ADA)

Time frame
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.
2

Peak concentration (Cmax), QW

The maximum serum concentration after administration

Time frame
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.
3

Peak concentration (Cmax), Q2W

The maximum serum concentration after administration

Time frame
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.
4

Peak concentration (Cmax), Q3W

The maximum serum concentration after administration

Time frame
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.

Other outcomes

Sponsors and contacts

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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now