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Clinical Studies for the Treatment of Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

This trial is part of a multicenter, open-label Phase Ib/II clinical study evaluating the efficacy, safety, and tolerability of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors. Phase Ib of Cohort A1 determines the dose of LM-108 in combination with penpulimab + oxaliplatin + capecitabine. Phase II explores the efficacy and safety of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be at least 18 years old.

The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1.

At least 1 measurable lesion as determined by RECIST v1.1 assessment. Positron emission tomography (PET) scans and ultrasonography cannot be used for diagnostic purposes.

All acute toxicities due to prior antineoplastic therapy or surgery have resolved to Grade 0-1 (according to NCI-CTCAE v5.0) or to the level specified by the enrollment/

Disqualifiers

Routine blood tests: (no transfusion, no granulocyte colony-stimulating factor (G-CSF), no drug correction) white blood cell count (WBC) ≥ 3,000/mm3 (3.0 × 109/L), neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L), platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L), hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L);

Biochemical tests: serum albumin ≥ 3.0 g/dL (30 g/L), serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (calculated using the Cockcroft-Gault formula), total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 2.5 times the upper limit of normal (ULN), and patients with liver metastases should ≤ 5× ULN;

The international normalized ratio (INR) is ≤ 1.5, and the prothrombin time (PT) and activated partial thromboplastin time (APTT) are ≤ 1.5 times ULN;

Urine protein< 2+; If the urine protein ≥ 2+, the 24-hour urine protein quantification shows that the protein must be ≤ 1 g;

Trial design

Design model

Parallel

Treatments tested in this trial

  • LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

    Drug

    LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody. Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

  • Tislelizumab+Oxaliplatin+Capecitabine

    Drug

    Tislelizumab is a humanized monoclonal antibody against Programmed cell death -Ligand-1(PD-1). Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

  • LM-108 injection 10mg/kg +penpulimab

    Drug

    LM-108injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

  • LM-108 injection 600mg + penpulimab

    Drug

    LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

  • enpulimab+ Oxaliplatin+Capecitabine

    Drug

    Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody. Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Treatment groups

194 Participants
are divided into 5 treatment groups
Group A: LM-108 injection+Penpulimab+ Oxaliplatin+CapecitabineExperimental treatment 1 intervention
Group B: Tislelizumab+Oxaliplatin+CapecitabineExperimental treatment 1 intervention
Group C: LM-108 injection 10mg/kg +penpulimabExperimental treatment 1 intervention
Group D: LM-108 injection 600mg + penpulimabExperimental treatment 1 intervention
Group E: Penpulimab+ Oxaliplatin+CapecitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLT) events

Incidence of Phase Ib DLT events for Cohort A1.

Time frame
From first dose to 21days after first dose
2

Progression-free survival (PFS)

Defined as the time from first dose to first occurrence of disease progression or death due to any cause.

Time frame
The estimated time from randomization to patient disease progression was 10 months

Secondary outcomes

1

Overall response rate (ORR)

After enrollment of all patients, the proportion of participants with the best overall efficacy rated as complete response or partial response according to criteria (RECIST1.1).

Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
2

Duration of response (DOR)

Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.

Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
3

Disease control rate (DCR)

Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients.

Time frame
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
4

Overall survival (OS)

The time from randomization to death due to any cause.

Time frame
From randomization until patient death, it is expected to be evaluated up to 5 years

Other outcomes

Sponsors and contacts

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

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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