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Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.

ConditionBreast Cancer (Triple Negative Breast Cancer (TNBC))
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Henlius Biotech

About this trial

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary written informed consent obtained before any study procedures.

Age ≥ 18 years at consent; no gender restriction.

Histopathologically confirmed TNBC: ER < 1%, PR < 1%, HER2 IHC 0/1+/2+ with no FISH amplification.

Phase I: Recurrent or metastatic TNBC after ≥1 prior line of standard systemic therapy.

Disqualifiers

Prior topoisomerase I-targeting therapy (e.g., irinotecan, topotecan, or ADCs).

Second primary malignancy within 2 years before randomization (except cured carcinoma in situ or stage I tumors).

Prior grade ≥3 immune-related adverse event during immunotherapy.

Uncontrolled, recurrent malignant pleural, pericardial, or ascitic effusions requiring repeated drainage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HLX43 DOSE 1 IN ≥2L TNBC

    Drug

    Dose 1; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 2 IN ≥2L TNBC

    Drug

    Dose 2; HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 1 + HLX10

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.

  • HLX43 DOSE1 IN 1L TNBC

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE 2 IN 1L TNBC

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

  • HLX43 DOSE2 + HLX10

    Drug

    HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8. HLX10 is a humanized anti-PD-1 monoclonal antibody that functions as an immune checkpoint inhibitor.

Treatment groups

180 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: armA: HLX43 DOSE 1 in ≥2L TNBCExperimental treatment 1 intervention
Group B: armB: HLX43 DOSE 2 in ≥2L TNBCExperimental treatment 1 intervention
Group C: armC: HLX43 DOSE 1 in 1L TNBCExperimental treatment 1 intervention
Group D: armD: HLX43 DOSE 2 in 1L TNBCExperimental treatment 1 intervention
Group E: armE: HLX43 DOSE 1+ HLX10 in 1L TNBCExperimental treatment 1 intervention
Group F: armF: HLX43 DOSE 2+ HLX10 in 1L TNBCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate (ORR) (assessed by BICR according to the RECIST v1.1 criteria)

Time frame
up to 24 weeks
2

PFS

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by BICR according to the RECIST v1.1 criteria.

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 10 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov

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