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Solid TumorPhase 1/2NCT04679038

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

A Phase 1/2 study testing SHR-1701 and Famitinib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
SHR-1701 and Famitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
16 sitesChina
Study dates
17 Mar 2021to 1 Oct 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Other protocol defined inclusion criteria could apply.

Who cannot join

  • 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.
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  • 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.
  • Other protocol defined exclusion criteria could apply.

Trial locations and contacts

16 sites in 1 country.

Linna Wang, MD contact

+86 13581990612

linna.wang@hengrui.com

Lu Wang, PhD contact

+86 13472607033

lu.wang@hengrui.com

16 sites in 1 country

China16 sites, 12 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Xu Zhu, Doctor

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Shanzhi Gu, Doctor

    Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Gannan, Jiangxi, 341000

    Jianming Ye, Doctor

    Recruiting

  • The 1st Affiliated Hospital of Zhejiang Medical University

    Hangzhou, Zhejiang, 310003

    Active, not recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Yuxian Bai, Doctor

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Active, not recruiting

  • The 2nd Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Zhendong Chen, Doctor

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250000

    Meili Sun, Doctor

    Recruiting

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

    Shukui Qin, Doctor

    Not yet recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

    Xuezhen Ma, Doctor

    Recruiting

  • Huashan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 022553

    Active, not recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

    Tianshu Liu, Doctor

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030000

    Mudan Yang, Doctor

    Recruiting

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300201

    Haitao Wang, Doctor

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Active, not recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yanru Qin, Doctor

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Solid Tumor
Being tested
SHR-1701, Famitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1701Biological

    Intravenous (IV) on Day 1 of each cycle

  • FamitinibDrug

    Famitinib, po, qd

Study groups in NCT04679038
Study groupRoleWhat they receive
combinational therapy partExperimentalSHR-1701 + famitinib
Receives: Biological: SHR-1701; Drug: Famitinib
monotherapy partExperimentalfamitinib
Receives: Drug: Famitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D

    Recommended phase-2 dosage

    Measured: First cycle (21 days)

  2. Objective response rate (ORR)

    Defined as complete or partial response per RECIST 1.1

    Measured: up to approximately 3 years (anticipated)

Secondary outcomes (12)

  1. Clinically Significant Toxicity

    Number of subjects in Phase I of combinational therapy part who experienced clinically significant toxicity

    Measured: First cycle (21 days)

  2. AEs+SAEs

    The incidence and severity of Adverse Events and Serious Adverse Events

    Measured: up to approximately 3 years (anticipated)

  3. DCR

    Disease Control Rate per RECIST 1.1

    Measured: up to approximately 3 years (anticipated)

  4. DoR

    Duration of Response per RECIST 1.1

    Measured: up to approximately 3 years (anticipated)

  5. PFS

    Progression-Free-Survival

    Measured: up to approximately 3 years (anticipated)

  6. OS

    OS is the time interval from the start of treatment to death from any cause or lost of follow-up

    Measured: up to approximately 3 years (anticipated)

  7. 6-month OS rate

    6-month-overall survival rate

    Measured: From the start of treatment to 6 months

  8. 12-month-OS rate

    12-month- overall survival rate

    Measured: From the start of treatment to 12 months

  9. Cmax of SHR-1701

    Maximum Plasma Concentration of SHR-1701

    Measured: up to approximately 3 years (anticipated)

  10. C6h of Famitinib

    Plasma Concentration of 6 hours after famitinb administration

    Measured: up to approximately 6 months (anticipated)

  11. Cmax,ss

    Measured: up to approximately 3 years (anticipated)

  12. AUC0-24h,ss

    Measured: up to approximately 3 years (anticipated)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start17 Mar 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
SHR-1701 plus famitinib
Masking
None (open label)
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04679038
Sponsor's protocol ID
SHR-1701-II-203
Status last verified
Jan 2022
First submitted
14 Dec 2020
Last updated
26 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1701 and Famitinib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Linna Wang, MD (+86 13581990612, linna.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: First cycle (21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04679038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.

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