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A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRisen (Suzhou) Pharma Tech Co., Ltd.

About this trial

This study is an open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS105 in combination with other anti-tumor therapies in patients with advanced solid tumors. Patients will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand and voluntarily sign the informed consent form;

18≤ age ≤ 75 years old, male or female;

Patients with histologically or cytologically confirmed recurrent/metastatic HR-positive and HER2-negative breast cancer;

HER2 negative must meet one of the following: IHC 0, IHC 1+; IHC2+ should be further confirmed by in situ hybridization (ISH) to determine HER2 negative, and different tissue blocks can also be selected for re-testing;

Disqualifiers

At least one measurable lesion (only for Phase II cohort expansion phase) or non-measurable osteolytic or mixed bone lesion (for breast cancer patients only) that meets the requirements of RECIST v1.1;

Eastern Cooperative Oncology (ECOG) performance status score: 0 or 1;

Expected survival ≥ 12 weeks;

Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the dosage form of the product;

Trial design

Design model

Sequential

Treatments tested in this trial

  • JS105

    Drug

    JS105 is administered once daily, orally

  • Fulvestrant injection

    Drug

    Fulvestrant intramuscularly,The first cycle was injected once in D1 and D15, and then once in each cycle D1, and 28 days was 1 cycle

  • Dalpiciclib Isetionate Tablets

    Drug

    Dalpiciclib Isetionate Tablets, QD, oral, taken continuously for 21 days, then stopped for 7 days, 28 days for a cycle

  • Toripalimab Injection

    Drug

    Toripalimab Injection,Intravenous infusion, once every 3 weeks, 21 days for 1 cycle

  • Paclitaxel for Injection (Albumin Bound)

    Drug

    Paclitaxel for Injection (Albumin Bound),Intravenous infusion, D1, 8, 15 infusion, every 28 days for a cycle

  • Fluzoparib Capsules

    Drug

    Fluzoparib Capsules is administered once daily, orally

  • Pyrotinib Maleate Tablets

    Drug

    Pyrotinib Maleate Tablets is administered once daily, orally

  • Capecitabine Tablets

    Drug

    Capecitabine Tablets is administered once daily, orally

Treatment groups

306 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Arm A:JS105+Fulvestrant InjectionExperimental treatment 2 interventions
Group B: Arm B:JS105+Fulvestrant Injection+Dalpiciclib Isetionate TabletsExperimental treatment 3 interventions
Group C: Arm C:JS105+Toripalimab InjectionExperimental treatment 2 interventions
Group D: Arm D:JS105+Paclitaxel for Injection (Albumin Bound)Experimental treatment 2 interventions
Group E: Arm E:JS105+Fluzoparib CapsulesExperimental treatment 2 interventions
Group F: Arm F:JS105+Pyrotinib Maleate Tablets+Capecitabine TabletsExperimental treatment 3 interventions
Group G: Arm G:JS105+Toripalimab Injection+Paclitaxel for Injection (Albumin Bound)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity

Incidence and severity of DLT events.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

MTD

Maximum tolerated dose

Time frame
At the end of Cycle 1 (each cycle is 28 days)
3

RP2D

Recommended phase II dose

Time frame
At the end of Cycle 1 (each cycle is 28 days)
4

Incidence and severity of adverse events including serious adverse events

Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

Time frame
Up to 2 years

Secondary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate (ORR) as Assessed by Investigator according to RECIST v1.1

Time frame
Up to 2 years
2

Duration of Objective Response (DOR)

Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1

Time frame
Up to 2 years
3

Disease Control Rate(DCR)

Disease Control Rate(DCR)

Time frame
Up to 2 years
4

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1

Time frame
Up to 2 years

Other outcomes

1

The proportion of patients with PIK3CA mutations in tumor remission

The proportion of patients with PIK3CA mutations in tumor remission

Time frame
Up to 2 years

Sponsors and contacts

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

Risen (Suzhou) Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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