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KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer

ConditionEsophageal Squamous Cell Carcinoma (ESCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Konruns Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18 to 75 years;

Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;

Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease;

At least one measurable tumor lesion according to RECIST 1.1;

Disqualifiers

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis;

Other malignancies within the past 5 years;

Known hypersensitivity to any monoclonal antibodies or chemotherapy components;

Gastrointestinal abnormalities;

Trial design

Design model

Parallel

Treatments tested in this trial

  • KC1036

    Drug

    Dosage: 20 mg, 30 mg, or 40 mg; Route: Oral; Frequency: Once daily (QD) under fasting conditions (at least 2 hours before and 1 hour after dosing), 21 days as a cycle.

  • Toripalimab

    Drug

    Dosage: 240 mg; Route: Intravenous (IV) infusion; Frequency: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle, for up to 2 years.

  • Paclitaxel

    Drug

    Dosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.

  • Cisplatin

    Drug

    Dosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.

  • KC1036

    Drug

    Dosage: Selected doses from Phase IIa (20 mg, 30 mg, or 40 mg); Route: Oral; Frequency: Once daily (QD) under fasting conditions, 21 days as a cycle.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Phase IIa (Dose Escalation and Expansion)Experimental treatment 4 interventions
Group B: Phase IIb (Randomized Expansion)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.

Time frame
Baseline to study completion (approximately 24 months)

Secondary outcomes

1

Progression-free survival (PFS)

PFS is defined as the time from the first study drug administration to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.

Time frame
Baseline to study completion (approximately 24 months)
2

Disease Control Rate (DCR)

DCR is defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.

Time frame
Baseline to study completion (approximately 24 months)
3

Duration of Response (DOR)

DOR is defined as the time from first documented objective response (complete response (CR)or partial response (PR)) to the date of first documented disease progression (PD) or death.

Time frame
Baseline to study completion (approximately 24 months).
4

TTR

TTR is defined as the time from the start of the first study drug administration to the date of the first documented response of complete response (CR) or partial response (PR) according to RECIST 1.1.

Time frame
Baseline to study completion (approximately 24 months)

Other outcomes

Sponsors and contacts

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

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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