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GB268 Monotherapy or Combination Therapy for Locally Advanced/Metastatic Breast Cancer (Phase Ib/Ⅱ)

ConditionBreast Cancer (Locally Advanced or Metastatic)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEddingpharm (Zhuhai) Co., Ltd.

About this trial

This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female.

Histologically confirmed locally advanced unresectable or metastatic breast cancer (Triple-Negative Breast Cancer [TNBC] or Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative [HR+/HER2-]).

At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1].

No prior treatment with any immune checkpoint inhibitor (e.g., anti-Programmed Death-1 [PD-1], anti-Programmed Death-Ligand 1 [PD-L1], anti-Cytotoxic T-Lymphocyte-Associated Protein 4 [CTLA-4]) or Programmed Death-1/Vascular Endothelial Growth Factor [PD-1/VEGF] bispecific antibody, except for adjuvant therapy if relapse occurred ≥12 months after discontinuation.

Disqualifiers

Prior anti-cancer therapy within specified washout periods.

Systemic immunosuppressive therapy within 2 weeks before first dose.

Major surgery or significant traumatic injury within 4 weeks before first dose.

Unresolved toxicity from prior therapy > Grade 1 (except alopecia or Grade ≤2 hypothyroidism stable on hormone replacement).

Trial design

Design model

Parallel

Treatments tested in this trial

  • GB268

    Drug

    GB268 is a tri-specific antibody targeting PD-1, CTLA-4, and VEGF. It is designed to block immune checkpoints (PD-1/CTLA-4) to enhance T-cell-mediated anti-tumor immune responses and simultaneously inhibit VEGF-mediated tumor angiogenesis

  • Nab-Paclitaxel

    Drug

    Nab-Paclitaxel is a microtubule-stabilizing agent formulated as albumin-bound nanoparticles for IV administration.

  • Datopotamab Deruxtecan (Dato-DXd)

    Drug

    Datopotamab Deruxtecan is an ADC targeting Trop-2, consisting of a monoclonal antibody linked to a topoisomerase I inhibitor payload.

  • Sacituzumab Tirumotecan

    Drug

    A Trop-2-directed Antibody-Drug Conjugate \[ADC\] consisting of a humanized anti-Trop-2 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload.

Treatment groups

270 Participants
are divided into 5 treatment groups
Group A: Cohort A (GB268 + Sacituzumab Tirumotecan)Experimental treatment 2 interventions
Group B: Cohort B (GB268 + Nab-Paclitaxel)Experimental treatment 2 interventions
Group C: Cohort E (GB268+ Datopotamab Deruxtecan)Experimental treatment 2 interventions
Group D: Cohort F (GB268 + Nab-Paclitaxel)Experimental treatment 2 interventions
Group E: Cohort G (GB268 monotherapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicities [DLTs] (Phase Ib)

Incidence of Dose-Limiting Toxicities \[DLTs\] during the first treatment cycle

Time frame
Within 21 days after first dose
2

Objective Response Rate [ORR] (Phase II)

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on Investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]

Time frame
Up to approximately 2 years

Secondary outcomes

1

Number of participants with adverse events [AEs] (Phase Ib and Phase II)

Safety as assessed by clinical laboratory tests, 12-lead electrocardiogram (ECG), vital signs measurements, and the incidence, nature and severity of all adverse events (AEs) and serious AEs (SAEs)

Time frame
Up to approximately 2 years
2

Objective Response Rate [ORR] (Phase Ib)

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Time frame
Up to approximately 2 years
3

Duration of Response [DOR] (Phase Ib and Phase II)

DOR assessed according to RECIST v1.1

Time frame
Up to approximately 2 years
4

Overall Survival [OS] (Phase Ib and Phase II)

OS defined as the time from the first dose to death from any cause

Time frame
Up to approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Eddingpharm (Zhuhai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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