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Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors

ConditionAdvanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years, male or female.

Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma.

For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and/or PD-(L)1 inhibitor therapy.

At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Disqualifiers

Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.

Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/exclusion criteria.

Presence of active central nervous system (CNS) metastases.

Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.

Trial design

Design model

Single group

Treatments tested in this trial

  • JS212 for Injection

    Drug

    administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS213 for Injection

    Drug

    administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS207 for Injection

    Drug

    administered by intravenous infusion on Day 1 of each 21-day cycle.

  • Toripalimab

    Drug

    administered by intravenous infusion on Day 1 of each 21-day cycle.

Treatment groups

410 Participants
are divided into 5 treatment groups
Group A: Arm 1: JS212 MonotherapyExperimental treatment 1 intervention
Group B: Arm 2: JS213 MonotherapyExperimental treatment 1 intervention
Group C: Arm 3: JS212 in Combination with JS213Experimental treatment 2 interventions
Group D: Arm 4: JS212 in Combination with JS207Experimental treatment 2 interventions
Group E: Arm 5: JS212 in Combination with ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate(ORR), assessed by investigator ( per RECIST v1.1).

Time frame
up to 6 years

Secondary outcomes

1

PFS

Progression-free survival (PFS), assessed by investigators (per RECIST v1.1)

Time frame
up to 6 years
2

DoR

Duration of response (DoR), assessed by investigators

Time frame
up to 6 years
3

DCR

Disease control rate (DCR), assessed by investigators

Time frame
up to 6 years
4

OS

overall survival (OS)

Time frame
up to 6 years

Other outcomes

Sponsors and contacts

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

Shanghai Junshi Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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