A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors

January 11, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

SHR-1701 Plus Famitinib Malate in Advanced Solid Tumors: An Open-label, Multi-center, Phase I/II Trial

This is an open-label, multi-center study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with metastatic or locally advanced solid tumor. There are two parts of the study: combinational therapy part and monotherapy part. Phase I of combinational therapy part is to determine the recommended dose for Phase II (RP2D) for famitinib in the combined regimen, then efficacy and safety of SHR-1701 plus famitinib (RP2D) will be further evaluated in the following Phase II in cohorts 1/2/3, with simon's two-stage design. Meanwhile, efficacy and safety of famitinib will also be assessed in cohorts 4/5 in the monotherapy part.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

222

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Anhui
      • Hefei, Anhui, China, 230001
        • Active, not recruiting
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The 2nd affiliated hospital of Anhui Medical University
        • Principal Investigator:
          • Zhendong Chen, Doctor
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Principal Investigator:
          • Xu Zhu, Doctor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Yanru Qin, Doctor
      • Zhengzhou, Henan, China, 450003
        • Active, not recruiting
        • Henan Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer hospital
        • Principal Investigator:
          • Shanzhi Gu, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Not yet recruiting
        • General Hospital of Eastern Theater Command
        • Principal Investigator:
          • Shukui Qin, Doctor
    • Jiangxi
      • Gannan, Jiangxi, China, 341000
        • Recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Principal Investigator:
          • Jianming Ye, Doctor
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Meili Sun, Doctor
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital
        • Principal Investigator:
          • Xuezhen Ma, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Principal Investigator:
          • Tianshu Liu, Doctor
      • Shanghai, Shanghai, China, 022553
        • Active, not recruiting
        • Huashan Hospital,Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Mudan Yang, Doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300201
        • Recruiting
        • The 2nd Hospital of Tianjin Medical University
        • Principal Investigator:
          • Haitao Wang, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Active, not recruiting
        • The 1st Affiliated Hospital of Zhejiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Phase I of combinational therapy part: Histologically proven metastatic or locally advanced solid tumors, for which no effective standard treatment exists or standard therapy has failed.
  2. Phase II of combinational therapy part and monotherapy part: Histologically confirmed metastatic or locally advanced selected solid tumor types with 0-2 prior lines of systemic therapy.

    For cohorts 1 or 4, patients with biliary tract carcinoma failed to one prior systemic treatment. Patients with previous adjuvant/neo-adjuvant therapy completed within 6 months can be enrolled.

    For cohort 2, patients with clear-cell renal cell carcinoma (or predominantly clear-cell subtype with primary tumor resected) after failure of no more than first-line standard therapy; For cohorts 3 or 5, patients with hepatocellular carcinoma must have progressed on prior first- or second-line standard therapy; Child-Pugh Class A; BCLC stage B or C, and not suitable for surgical or local therapy.

  3. Subjects are 18 years old or older when signing the informed consent and gender is not limited.
  4. Life expectancy of at least 12 weeks.
  5. Eastern Cooperative Group (ECOG) performance status of 0 to 1.
  6. At least one measurable lesion according to RECIST version 1.1.
  7. Tumor tissue must be available for biomarker analysis prior to the first dose of treatment, If not available, subjects can consult the investigator for enrollment agreement.
  8. Adequate hematological, hepatic and renal function as defined in the protocol.
  9. Subjects with HBV infection: HBV DNA<500 IU/mL or < 2500 copy/mL, must receive anti-HBV therapy.
  10. Subjects with HCV-RNA(+) must receive antiviral therapy.
  11. Able and willing to provide signed informed consent form, and able to comply with all procedures.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

  1. For cohorts 1 or 4: known ampullary cancer or mixed cancer (HCC-ICC).
  2. For cohorts 3 or 5: known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; history of hepatic encephalopathy.
  3. For subjects in combinational therapy part: prior treatment with any anti-PD-1/PD-L1, or anti-CTLA-4 agents (specifically targeting T-cell co-stimulation or checkpoint pathways), or TGF-β inhibitors.
  4. For cohort 4: prior treatment with VEGFR directed therapies including famitinib.
  5. Factors to affect oral administration.
  6. Major surgery procedure within 28 days prior to the first dose of trial treatment (excluding prior diagnostic biopsy or PICC); anticancer treatment within 28 days before the first dose of trial treatment; subjects in combinational therapy part who have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment should also be excluded.
  7. Moderate-to-severe ascites with clinical symptoms.
  8. Active or history of central nervous system metastases.
  9. Known genetic or acquired hemorrhage or thrombotic tendency.
  10. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.

Other protocol defined exclusion criteria could apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combinational therapy part
SHR-1701 + famitinib
Famitinib, po, qd
Intravenous (IV) on Day 1 of each cycle
Experimental: monotherapy part
famitinib
Famitinib, po, qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RP2D
Time Frame: First cycle (21 days)
Recommended phase-2 dosage
First cycle (21 days)
Objective response rate (ORR)
Time Frame: up to approximately 3 years (anticipated)
Defined as complete or partial response per RECIST 1.1
up to approximately 3 years (anticipated)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Significant Toxicity
Time Frame: First cycle (21 days)
Number of subjects in Phase I of combinational therapy part who experienced clinically significant toxicity
First cycle (21 days)
AEs+SAEs
Time Frame: up to approximately 3 years (anticipated)
The incidence and severity of Adverse Events and Serious Adverse Events
up to approximately 3 years (anticipated)
DCR
Time Frame: up to approximately 3 years (anticipated)
Disease Control Rate per RECIST 1.1
up to approximately 3 years (anticipated)
DoR
Time Frame: up to approximately 3 years (anticipated)
Duration of Response per RECIST 1.1
up to approximately 3 years (anticipated)
PFS
Time Frame: up to approximately 3 years (anticipated)
Progression-Free-Survival
up to approximately 3 years (anticipated)
OS
Time Frame: up to approximately 3 years (anticipated)
OS is the time interval from the start of treatment to death from any cause or lost of follow-up
up to approximately 3 years (anticipated)
6-month OS rate
Time Frame: From the start of treatment to 6 months
6-month-overall survival rate
From the start of treatment to 6 months
12-month-OS rate
Time Frame: From the start of treatment to 12 months
12-month- overall survival rate
From the start of treatment to 12 months
Cmax of SHR-1701
Time Frame: up to approximately 3 years (anticipated)
Maximum Plasma Concentration of SHR-1701
up to approximately 3 years (anticipated)
C6h of Famitinib
Time Frame: up to approximately 6 months (anticipated)
Plasma Concentration of 6 hours after famitinb administration
up to approximately 6 months (anticipated)
Cmax,ss
Time Frame: up to approximately 3 years (anticipated)
up to approximately 3 years (anticipated)
AUC0-24h,ss
Time Frame: up to approximately 3 years (anticipated)]
up to approximately 3 years (anticipated)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1701-II-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumor

Clinical Trials on Famitinib

3
Subscribe