KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma

April 25, 2023 updated by: Shanghai Kanda Biotechnology Co., Ltd.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of KD6001 in Combination With Anti-PD-1 Antibody in Patients With Advanced Melanoma

This is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of KD6001 in combination with toripalimab in patients with advanced melanoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. Being voluntary to sign the informed consent form.
  2. Male or female, aged ≥ 18 years.
  3. Patients whose estimated survival time is more than 3 months.
  4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
  5. Histologically or cytologically confirmed advanced or metastatic melanoma, and the overall proportion of subjects with mucosal malignant melanoma will not exceed 22%.
  6. At least one measurable lesion is used as the target lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
  7. The results of laboratory examination during the screening period suggest that the subjects have good organ function.
  8. Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
  9. Good compliance and follow-up.

Main Exclusion Criteria:

  1. Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
  2. Received immunotherapy (including PD-1/PD-L1 therapy and cell therapy) within 4 weeks prior to the start of this study.
  3. Prior treatment with anti-CTLA-4 antibody.
  4. Subjects with an active, known or suspected autoimmune disease.
  5. Subjects with hepatitis (nonalcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and liver cirrhosis; active hepatitis B or hepatitis C.
  6. Subjects with an active infection requiring systemic treatment.
  7. Known history of testing positive for human immunodeficiency virus (HIV).
  8. Subjects known to have active tuberculosis (TB).
  9. Known to be allergic to KD6001 or Toripalimab and its components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KD6001+Toripalimab
KD6001 combined with toripalimab in patients with advanced melanoma
Drug: KD6001
KD6001 will be administered intravenously.
Drug: Toripalimab
Toripalimab will be administered intravenously.
Other Names:
  • JS001

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame: Up to Day 21
DLTs will be assessed during the dose-escalation phase and are defined as the following treatment-related adverse events occurring within a total of 21 days after the first trial administration.
Up to Day 21
The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)
Time Frame: Baseline to study completion up to 2 years
Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).
Baseline to study completion up to 2 years
Maximum tolerated dose (MTD)
Time Frame: Up to Day 21
The maximum tolerated dose (MTD) of KD6001 combined with toripalimab
Up to Day 21
Recommended Phase II dose (RP2D)
Time Frame: Up to Day 21
Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab
Up to Day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The antitumor activity of KD6001 in combination with Toripalimab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST 1.1
Time Frame: Baseline to study completion up to 2 years
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and modified RECIST 1.1
Baseline to study completion up to 2 years
The PK profile of KD6001 in combination with Toripalimab
Time Frame: Baseline to study completion up to 2 years
Drug concentration of individual subject at different time points after administration; Pharmacokinetic parameters
Baseline to study completion up to 2 years
The immunogenicity of KD6001 in combination with Toripalimab
Time Frame: Baseline to study completion up to 2 years
Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) will be analyzed.
Baseline to study completion up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Kanda Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KD6001CT02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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