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

NCT04679038 | Unknown Phase 1

• 1 other identifier: SHR-1701-II-203
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• RP2D

  Recommended phase-2 dosage

  First cycle (21 days)

• Objective response rate (ORR)

  Defined as complete or partial response per RECIST 1.1

  up to approximately 3 years (anticipated)

Secondary Outcomes (12)

• Clinically Significant Toxicity

  First cycle (21 days)

• AEs+SAEs

  up to approximately 3 years (anticipated)

• DCR

  up to approximately 3 years (anticipated)

• DoR

  up to approximately 3 years (anticipated)

• PFS

  up to approximately 3 years (anticipated)

Study Arms (2)

combinational therapy part

EXPERIMENTAL

SHR-1701 + famitinib

Biological: SHR-1701; Drug: Famitinib

monotherapy part

EXPERIMENTAL

famitinib

Drug: Famitinib

Interventions

SHR-1701 BIOLOGICAL

Intravenous (IV) on Day 1 of each cycle

combinational therapy part

Famitinib DRUG

Famitinib, po, qd

combinational therapy part; monotherapy part

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• Subjects are 18 years old or older when signing the informed consent and gender is not limited.
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Group (ECOG) performance status of 0 to 1.
• At least one measurable lesion according to RECIST version 1.1.
• 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.
• Adequate hematological, hepatic and renal function as defined in the protocol.
• Subjects with HBV infection: HBV DNA\<500 IU/mL or \< 2500 copy/mL, must receive anti-HBV therapy.
• Subjects with HCV-RNA(+) must receive antiviral therapy.
• Able and willing to provide signed informed consent form, and able to comply with all procedures.

You may not qualify if:

• For cohorts 1 or 4: known ampullary cancer or mixed cancer (HCC-ICC).
• For cohorts 3 or 5: known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; history of hepatic encephalopathy.
• 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.
• For cohort 4: prior treatment with VEGFR directed therapies including famitinib.
• Factors to affect oral administration.
• 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.
• Moderate-to-severe ascites with clinical symptoms.
• Active or history of central nervous system metastases.
• Known genetic or acquired hemorrhage or thrombotic tendency.
• History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (16)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

ACTIVE NOT RECRUITING

The 2nd Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210002, China

NOT YET RECRUITING

First Affiliated Hospital of Gannan Medical University

Gannan, Jiangxi, 341000, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250000, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 022553, China

ACTIVE NOT RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

The 2nd Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300201, China

RECRUITING

The 1st Affiliated Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, 310003, China

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

SHR-1701; famitinib

Central Study Contacts

Linna Wang, MD

CONTACT

+86 13581990612; linna.wang@hengrui.com

Lu Wang, PhD

CONTACT

+86 13472607033; lu.wang@hengrui.com

Study Design

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

Model Details: SHR-1701 plus famitinib

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 22, 2020
• Study Start: March 17, 2021
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)