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

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05944224
• Collaborator: (none)
• Enrollment: 63
• Locations: 16
• Arms: 3
• Anticipated Duration (Months): 26.4
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: SPH4336; Drug: Cadonilimab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.
• Anticipated Study Start Date: Oct 18, 2023
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPH4336	Drug: SPH4336; SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Experimental: Cadonilimab	Drug: Cadonilimab; Intravenous infusion, 6mg/Kg,28 days/cycle
Experimental: SPH4336+ Cadonilimab	Drug: SPH4336; SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle; Drug: Cadonilimab; Intravenous infusion, 6mg/Kg,28 days/cycle

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) [Approximately 2 years]

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

Secondary Outcome Measures

1. Objective response rate (ORR) [Approximately 2 years]

   Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

2. progression-free rate（PFR） [Approximately 2 years]

   Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.

3. Cmax [Approximately 2 years]

   PK (Pharmacokinetics) parameters.

4. Tmax [Approximately 2 years]

   PK (Pharmacokinetics) parameters.

5. Disease control rate (DCR) [Approximately 2 years]

   DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.

6. Duration of remission (DOR) [Approximately 2 years]

   DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.

7. Overall Survival (OS) [Approximately 8 years]

   Determination of the overall survival times of all patients.

8. Incidence of Adverse event [Approximately 2 years]

   Safety and tolerability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects voluntarily participate in this study and sign informed consent.

2. Expected survival ≥3 months.

3. Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.

4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.

5. The laboratory test results meet the organ function requirements before starting the study treatment.

6. 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.

7. Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.

Exclusion Criteria:

1. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.

2. Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.

3. Had a history of other malignancies before starting the study.

4. 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%.

5. 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.

6. Previous history of organ transplantation.

7. 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.

8. Accompanied by any other serious, progressive, or uncontrolled disease.

9. Subjects with a known history of immune-related adverse events that the investigator determined could not be included.

10. History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.

11. Women who are pregnant or breastfeeding.

12. Any other reason for which patients are ineligible for the study as assessed by the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Cancer Hospital	Fuzhou	Fujian	China
2	The First Affiliated Hospital，Sun Yat-sen University	Guangzhou	Guangdong	China
3	Henan Cancer Hospital	Zhengzhou	Henan	China
4	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	China
5	Xiangya Hospital Central South University	Changsha	Hunan	China
6	The Central Hospital of Yongzhou	Yongzhou	Hunan	China
7	Liaoning Cancer Hospital & Institute	Shenzhen	Liaoning	China
8	Xijing Hospital	Xi'an	Shanxi	China
9	West China Hospital，Sichuan University	Chengdu	Sichuan	China
10	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
11	Zhejiang cancer Hospital	Hangzhou	Zhejiang	China
12	Peking Union Medical College Hospital	Beijing		China
13	Peking University People's Hospital	Beijing		China
14	Fudan University Shanghai Cancer Center	Shanghai		China
15	Shanghai Sixth People's Hospital	Shanghai		China
16	Tianjin Medical University Cancer Institute & Hospital	Tianjin		China

Sponsors and Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Pharmaceuticals Holding Co., Ltd
• ClinicalTrials.gov Identifier: NCT05944224
• Other Study ID Numbers: SPH4336-201
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jul 13, 2023