A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.

NCT05944224 | Recruiting Phase 1

• 1 other identifier: SPH4336-201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 16

Brief Summary

This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From the start date of study treatment to the date of progression disease or death , whichever occurred first.

  Approximately 2 years

Secondary Outcomes (8)

• Objective response rate (ORR)

  Approximately 2 years

• progression-free rate（PFR）

  Approximately 2 years

• Cmax

  Approximately 2 years

• Tmax

  Approximately 2 years

• Disease control rate (DCR)

  Approximately 2 years

Study Arms (3)

SPH4336

EXPERIMENTAL

Drug: SPH4336

Cadonilimab

EXPERIMENTAL

Drug: Cadonilimab

SPH4336+ Cadonilimab

EXPERIMENTAL

Drug: SPH4336; Drug: Cadonilimab

Interventions

SPH4336 DRUG

SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle

SPH4336; SPH4336+ Cadonilimab

Cadonilimab DRUG

Intravenous infusion, 6mg/Kg,28 days/cycle

Cadonilimab; SPH4336+ Cadonilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in this study and sign informed consent.
• Expected survival ≥3 months.
• Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
• According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
• The laboratory test results meet the organ function requirements before starting the study treatment.
• Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
• Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.

You may not qualify if:

• Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
• Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
• Had a history of other malignancies before starting the study.
• History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
• Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
• Previous history of organ transplantation.
• Before starting the study, HBsAg positive patients with HBV DNA \> 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
• Accompanied by any other serious, progressive, or uncontrolled disease.
• Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
• History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
• Women who are pregnant or breastfeeding.
• Any other reason for which patients are ineligible for the study as assessed by the investigator.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (16)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital，Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, He'nan, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenzhen, Liaoning, China

RECRUITING

Xijing Hospital

Xi’an, Shanxi, China

RECRUITING

West China Hospital，Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Peking University People's Hospital

Beijing, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Haiyan Hu

CONTACT

0086-020-87343535; xuri1104@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (16)