Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07481058
KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
A Phase 2 study testing KC1036, Toripalimab and Paclitaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- KC1036, Toripalimab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Life expectancy > 12 weeks;
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- BMI≥16.0 kg/m2;
- Adequate bone marrow, renal, and hepatic function;
- Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose;
- Patients should participate in the study voluntarily and sign informed consent.
Who cannot join
- 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;
- High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula;
- Cardiovascular and cerebrovascular diseases;
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- Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
- Active autoimmune disease or a history of autoimmune disease requiring systemic treatment;
- Active infections, including severe infection (CTCAE > Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV;
- Pregnant or lactating women;
- Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study;
- Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Jing Huang, Ph.D, 010-87788293, huangjingwg@163.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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).
Read the detailed description
This multicenter Phase II study evaluates KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma. The trial comprises a Phase IIa dose-escalation and expansion phase to assess the safety of KC1036 at 20, 30, or 40 mg QD, followed by a Phase IIb randomized evaluation of 2-3 cohorts (up to 50 subjects per arm) to identify the recommended Phase III dose. Subjects receive daily oral KC1036 plus toripalimab, paclitaxel, and cisplatin every 3 weeks until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
- Being tested
- KC1036, Toripalimab, Paclitaxel, Cisplatin
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
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.
ToripalimabDrug
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.
PaclitaxelDrug
Dosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
CisplatinDrug
Dosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
KC1036Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase IIa (Dose Escalation and Expansion) | Experimental | This is a multicenter, single-arm, dose-escalation and expansion phase. Subjects will receive KC1036 at one of three dose levels (20 mg QD, 30 mg QD, or 40 mg QD) in combination with fixed doses of Toripalimab and platinum-based chemotherapy (Paclitaxel and Cisplatin). Receives: Drug: KC1036; Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin |
| Phase IIb (Randomized Expansion) | Experimental | This is a multicenter, randomized, parallel-group, open-label phase. Based on Phase IIa results, 2-3 dose cohorts will be selected. Subjects will be randomized (1:1 or 1:1:1) to receive the assigned dose of KC1036 in combination with Toripalimab and platinum-based chemotherapy. Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion (approximately 24 months)
Secondary outcomes (5)
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.
Measured: Baseline to study completion (approximately 24 months)
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.
Measured: Baseline to study completion (approximately 24 months)
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.
Measured: Baseline to study completion (approximately 24 months).
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.
Measured: Baseline to study completion (approximately 24 months)
Adverse events (AEs)
Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start12 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481058
- Sponsor's protocol ID
- KC1036-COM-01
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07481058
- Acronym / sponsor ID
- KC1036-COM-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This multicenter Phase II study evaluates KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma. The trial comprises a Phase IIa dose-escalation and expansion phase to assess the safety of KC1036 at 20, 30, or 40 mg QD, followed by a Phase IIb randomized evaluation of 2-3 cohorts (up to 50 subjects per arm) to identify the recommended Phase III dose. Subjects receive daily oral KC1036 plus toripalimab, paclitaxel, and cisplatin every 3 weeks until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase IIa (Dose Escalation and Expansion) | Experimental | Drug: KC1036, Drug: Toripalimab, Drug: Paclitaxel, Drug: CisplatinThis is a multicenter, single-arm, dose-escalation and expansion phase. Subjects will receive KC1036 at one of three dose levels (20 mg QD, 30 mg QD, or 40 mg QD) in combination with fixed doses of Toripalimab and platinum-based chemotherapy (Paclitaxel and Cisplatin). |
| Phase IIb (Randomized Expansion) | Experimental | Drug: Toripalimab, Drug: Paclitaxel, Drug: Cisplatin, Drug: KC1036This is a multicenter, randomized, parallel-group, open-label phase. Based on Phase IIa results, 2-3 dose cohorts will be selected. Subjects will be randomized (1:1 or 1:1:1) to receive the assigned dose of KC1036 in combination with Toripalimab and platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
Key exclusion criteria (14 listed)
- 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;
- High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC1036Dosage: 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. | Drug | Phase IIa (Dose Escalation and Expansion) |
| ToripalimabDosage: 240 mg; Route: Intravenous (IV) infusion; Frequency: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle, for up to 2 years. | Drug | Phase IIa (Dose Escalation and Expansion), Phase IIb (Randomized Expansion) |
| PaclitaxelDosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles. | Drug | Phase IIa (Dose Escalation and Expansion), Phase IIb (Randomized Expansion) |
| CisplatinDosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles. | Drug | Phase IIa (Dose Escalation and Expansion), Phase IIb (Randomized Expansion) |
| KC1036Dosage: 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. | Drug | Phase IIb (Randomized Expansion) |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline to study completion (approximately 24 months)
ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Baseline to study completion (approximately 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (approximately 24 months).
TTR
Time frame: Baseline to study completion (approximately 24 months)
Adverse events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KC1036, Toripalimab and Paclitaxel in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, Ph.D (+86-010-87788293, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Baseline to study completion (approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.