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MelanomaPhase 1/2NCT05723432

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

A Phase 1/2 study testing KD6001 and Toripalimab in people with Melanoma, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
KD6001 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
22 Mar 2023to 31 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Chi Zhang contact

+8615800854907

zhangchi@kandatech.cn

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    Jun Guo, MD, 010-88121122, guoj307@126.com

    Jun Guo, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Melanoma
Being tested
KD6001, Toripalimab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KD6001Drug

    KD6001 will be administered intravenously.

  • ToripalimabDrug

    Also called JS001

    Toripalimab will be administered intravenously.

Study groups in NCT05723432
Study groupRoleWhat they receive
KD6001+ToripalimabExperimentalKD6001 combined with toripalimab in patients with advanced melanoma
Receives: Drug: KD6001; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    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.

    Measured: Up to Day 21

  2. The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)

    Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).

    Measured: Baseline to study completion up to 2 years

  3. Maximum tolerated dose (MTD)

    The maximum tolerated dose (MTD) of KD6001 combined with toripalimab

    Measured: Up to Day 21

  4. Recommended Phase II dose (RP2D)

    Recommended Phase 2 dose (RP2D) of KD6001 combined with toripalimab

    Measured: Up to Day 21

Secondary outcomes (3)

  1. 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

    Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and modified RECIST 1.1

    Measured: Baseline to study completion up to 2 years

  2. The PK profile of KD6001 in combination with Toripalimab

    Drug concentration of individual subject at different time points after administration; Pharmacokinetic parameters

    Measured: Baseline to study completion up to 2 years

  3. The immunogenicity of KD6001 in combination with Toripalimab

    Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (NAB) will be analyzed.

    Measured: Baseline to study completion up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start22 Mar 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723432
Sponsor's protocol ID
KD6001CT02
Status last verified
Apr 2023
First submitted
3 Feb 2023
Last updated
27 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KD6001 and Toripalimab in people with Melanoma, run by Shanghai Kanda Biotechnology 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?

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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chi Zhang (+8615800854907, zhangchi@kandatech.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to Day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723432.

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 27 Apr 2023.

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