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

NCT06208410 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-07-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

JS105

JS105 is administered once daily, orally

DRUG

Fulvestrant injection

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

DRUG

Dalpiciclib Isetionate Tablets

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

DRUG

Toripalimab Injection

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

DRUG

Paclitaxel for Injection (Albumin Bound)

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

DRUG

Fluzoparib Capsules

Fluzoparib Capsules is administered once daily, orally

DRUG

Pyrotinib Maleate Tablets

Pyrotinib Maleate Tablets is administered once daily, orally

DRUG

Capecitabine Tablets

Capecitabine Tablets is administered once daily, orally

Sponsors & Collaborators

  • Risen (Suzhou) Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2027-02-26
Completion
2027-02-26

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06208410 on ClinicalTrials.gov