The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05836948
• Collaborator: (none)
• Enrollment: 174
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: SHR-9839	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 174 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-9839 three stages: dose escalation, dose expansion and efficacy expansion.	Drug: SHR-9839; Weekly fixed dose injection of SHR-9839

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose (MTD) or maximum administered dose (MAD) [On the first day of each week,4 weeks is a treatment cycle]

   Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment

2. Recommended Phase 2 dose (RP2D) [From Day 1 to 90 days after last dose]

   RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.

3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) [From Day 1 to 90 days after last dose]

   Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).

Secondary Outcome Measures

1. PK parameter: Tmax of SHR-9839 [approximately 10 months]

   Time to maximum concentration of SHR-9839

2. PK parameter: Cmax of SHR-9839 [approximately 10 months]

   Maximum concentration of SHR-9839

3. PK parameter: AUC0-t of SHR-9839 [Approximately 10 months]

   Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839

4. PK parameter: AUC0-∞ of SHR-9839 [Approximately 10 months]

   Area under the concentration-time curve from time 0 to infinity of SHR-9839

5. Immunogenicity of SHR-9839 [Approximately 12 months]

   Anti-SHR-9839 antibody (ADA)

6. Overall response rate (ORR) [Approximately within 36 months]

   Evaluated using RECIST 1.1

7. Duration of response (DoR) [Approximately within 36 months]

   Evaluated using RECIST 1.1

8. Disease control rate (DCR) [Approximately within 36 months]

   Evaluated using RECIST 1.1

9. Progression-free survival (PFS) [Approximately within 36 months]

   Evaluated using RECIST 1.1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;

2. Have at least one measurable tumor lesion per RECIST v1.1;

3. ECOG performance status of 0-1;

4. Life expectancy ≥ 12 weeks;

5. Adequate bone marrow and organ function;

6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;

2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;

3. History of serious cardiovascular and cerebrovascular diseases;

4. Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;

5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Tumor Hospital	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Hengrui Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05836948
• Other Study ID Numbers: SHR-9839-I-101
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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 May 1, 2023