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

ConditionAdvanced Malignant Solid Tumors

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 to 75 years old (inclusive) at the time of signing the ICF;

Patients with histologically or cytologically confirmed advanced malignant solid tumors；

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

Life expectancy ≥ 12 weeks;

Disqualifiers

CNS metastasis；

Pleural effusion, peritoneal effusion or pericardial effusion with clinical symptoms or requiring repeated treatment (e.g., puncture or drainage);

Unable to swallow tablets, intestinal obstruction, or other factors affecting the administration and gastrointestinal absorption of tablets

Having received chemotherapy, immunotherapy or other anti-tumor therapy or other investigational drug within 21 days prior to the first dose, or having received oral fluorouracil, small-molecule targeted drugs or Chinese herbal products for antitumor indications within 14 days prior to the first dose;

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

93 Participants

are divided into 3 treatment groups

Group A: WJ47156Experimental treatment 1 intervention

Group B: WJ47156+JS001+BevacizumabExperimental treatment 1 intervention

Group C: WJ47146+JS207Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1.DLT

Safety endpoints: incidence and severity of DLT

Time frame

1 years

2、AE

Safety endpoints: incidence and severity of adverse events (AE); Abnormal changes in laboratory and other tests with clinical significance

Time frame

2.5 years

3、SAE

Safety endpoints: incidence and severity of serious adverse events (SAE); Abnormal changes in laboratory and other tests with clinical significance

Time frame

2.5 years

4.MTD

Maximum tolerated dose (MTD)

Time frame

1 year

Secondary outcomes

6.ORR

Efficacy endpoints: Objective response rate (ORR) per RECIST v1.1

Time frame

2 years

7.DOR

Efficacy endpoints: Duration of response (DOR) per RECIST v1.1

Time frame

2 years

8.DCR

Efficacy endpoints: Disease control rate (DCR) per RECIST v1.1

Time frame

2 years

9.PFS

Efficacy endpoints: Progression-free survival (PFS) per RECIST v1.1

Time frame

2 years

Other outcomes

QT interval

To evaluate the correlation between plasma concentration of WJ47156 and QT interval (only applicable to the dose group of 30 mg and above of WJ47156 monotherapy)

Time frame

2 years

Anti-drug antibody (ADA)

To evaluate the immunogenicity of toripalimab and JS207, including the incidence and titer of anti-drug antibody (ADA), if ADA positive, the neutralizing antibody (Nab) as needed

Time frame

2 years

Blood concentration

Blood concentration of toripalimab and JS207

Time frame

2 years