Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT06571422
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • WJ47156 — DRUG
    Monotherapy study: participate will recepit WJ47156 monotherpy with 3 dose groups; Combination therapy study: participate will recepit WJ47156 and other study drug if in the combination therapy period
  • JS001+Bevacizumab — DRUG
    Participants in Cohort1 of combination therapy phase will receive WJ47156 plus toripalimab and bevacizumab.Toripalimab and bevacizumab are administered intravenously.
  • JS207 — DRUG
    Participants in Cohort2 of combination therapy phase will receive WJ47156 plus JS207. JS207 is administered intravenously.

Study Details

This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).

Key Dates

First listed
Aug 26, 2024
Start date
Oct 23, 2024
Status verified
Jul 2026
Primary completion
Dec 15, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WJ47156
    If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
  • Experimental: WJ47156+JS001+Bevacizumab
    If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
  • Experimental: WJ47146+JS207
    If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.

Primary Outcome Measure

1.DLT [ Time Frame: 1 years ]

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