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JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer

ConditionCervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

The goal of this clinical trial is to learn if the therapy of JSKN033 plus chemotherapy with or with bevacizumab is safe to treat patients with advanced cervical cancer. It will also learn about the antitumor activity and pharmacokinetic/ pharmacodynamic profiles of this therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate and sign the informed consent form.

Age ≥ 18 years old, male or female.

Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Expected survival ≥ 3 months.

Disqualifiers

Complicated with other malignant tumors within 3 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk.

History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.

Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.

Prior treatment with topoisomerase I inhibitors or antibody-drug conjugates containing topoisomerase I inhibitors.

Trial design

Design model

Sequential

Treatments tested in this trial

  • JSKN033

    Drug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

  • Platinum

    Drug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

  • Bevacizumab

    Drug

    JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol

Treatment groups

78 Participants
are divided into 3 treatment groups
Group A: Safety run-in dose cohort 1Experimental treatment 3 interventions
Group B: Safety run-in dose cohort 2Experimental treatment 3 interventions
Group C: Dose expansion cohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)

Time frame
21 days from the first dose
2

Frequency and severity of Treatment-Related Adverse Events (TRAEs)

Time frame
21 days from the first dose
3

Frequency and severity of Serious Adverse Events (SAEs)

Time frame
21 days from the first dose
4

Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.

Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.

Secondary outcomes

1

Disease Control Rate (DCR)

Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
2

Time to Response (TTR)

Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months
3

Duration of Response (DoR)

Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
4

Progression-Free Survival (PFS) as assessed by the investigator and IRC per RECIST 1.1

Time frame
From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.

Other outcomes

Sponsors and contacts

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

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: