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Advanced Solid TumorsPhase 1NCT03545971

A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.

A Phase 1 study testing IBI310 and Sintilimab in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced melanoma(Ib). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
IBI310 and Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
25 Sep 2018to 9 Aug 2022
Phase
Phase 1
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with locally advanced, recurrent or metastatic solid tumors who failed standard treatment(applicable to the Ia period).
  • Patients with advanced, recurrent or metastatic melanoma confirmed by cytology or histology (applicable to the Ib period).
  • Signed written informed consent form and willing and able to comply with scheduled visits and other requirements of the study.
  • ≥18，and ≤70 years.
  • Life expectancy of at least 12 weeks.
  • At least 1 measurable lesion per RECIST v1.1(long axis>15mm or short axis>10mm)
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  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
  • Patients of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study medication.
  • Adequate organ and bone marrow function.

Who cannot join

  • Prior exposure to any anti-CTLA-4, anti-PD-1 or anti-PD-L1/L2 antibody.
  • Received any investigational agent within 4 weeks of the first dose of study medication.
  • Received last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor immunotherapy or arterial embolization) within 4 weeks of the first dose of study medication.
  • Received treatment with corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks before the first dose of study medication. Nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids are not included.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (Patients with vitiligo, psoriasis, alopecia or Grave's disease, hypothyroidism requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll)
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  • Known primary immunodeficiency
  • Active tuberculosis
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
  • Known allergy or hypersensitivity to any other monoclonal antibodies or IBI310 and/or any components used in their preparation.
  • Known acute or chronic active hepatitis B (HBV DNA positive and HBV DNA copies ≥1×103/ml or ≥200IU/ml) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection. Patients with HCV antibody positive but HCV RNA negative are permitted to enroll.
  • Patients with a history of interstitial lung disease
  • Uncontrolled third space effusion, eg. ascites or pleural effusion cannot be drained or controlled.
  • Women who are pregnant or nursing.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase I, Open-Label Study to Investigate the Tolerability and Safety of IBI310 Alone or in Combination With Sintilimab in the Treatment of Patients With Advanced Solid Tumors.

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced melanoma(Ib).

Read the detailed description

Phase Ia study will adopt the classical 3+3 dose escalation design. The starting dose is 0.3 mg/kg, followed by 3 dose cohorts (1mg/kg, 2mg/kg and 3mg/kg). Duration of dose limiting toxicity (DLT) observation period is 21 days. IBI310 treatment q3w, up to 3 cycles, will be provided to patients who complete DLT observation period.

Efficacy will primarily be evaluated by RECIST v1.1. Patient safety will be monitored throughout the study. Pharmacokinetic/pharmacodynamics and immunogenicity will be assessed throughout the study.

Phase Ib study will evaluate the tolerability and safety of IBI310 combined with Sintilimab in patients with advanced melanoma. Phase Ib of the study will begin after DLT observation is completed in certain dose cohorts.

Being tested
IBI310, Sintilimab

What participants receive

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

  • IBI310Drug

    Also called CTLA-4

    IBI310 is anti CTLA-4 antibody

  • SintilimabDrug

    PD-1 monoclonal antibody

Study groups in NCT03545971
Study groupRoleWhat they receive
Ia Cohort AExperimentalLow-dose group:Participants will receive IBI310 0.3mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity.
Receives: Drug: IBI310
Ia Cohort BExperimentalMiddle-dose group:Participants will receive IBI310 1.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity
Receives: Drug: IBI310
Ia Cohort CExperimentalMiddle-dose group:Participants will receive IBI310 2.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity
Receives: Drug: IBI310
Ia Cohort DExperimentalHigh-dose group:Participants will receive IBI310 3.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity
Receives: Drug: IBI310
Ib Cohort AExperimental3 subjects, low-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.
Receives: Drug: IBI310; Drug: Sintilimab
Ib Cohort A2Experimentallow-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.
Receives: Drug: IBI310; Drug: Sintilimab
Ib Cohort BExperimental3 subjects, low-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.
Receives: Drug: IBI310; Drug: Sintilimab
Ib Cohort B2Experimentallow-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.
Receives: Drug: IBI310; Drug: Sintilimab

What is being measured

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

  1. AEs

    Number of patients with treatment-related adverse events (AEs)

    Measured: up to 24 months after randomization

Secondary outcomes (4)

  1. Pharmacokinetics：Cmax

    Maximum concentration(Cmax) of the drug after administration

    Measured: up to 24 months after randomization

  2. pharmacodynamics:lipid parameters

    Change from baseline in lipid parameters

    Measured: up to 24 months after randomization

  3. ADA

    Number of participants with anti-drug antibodies or neutralizing antibodies

    Measured: up to 24 months after randomization

  4. Pharmacokinetics：AUC

    The area under the curve (AUC) of serum concentration of the drug after the administration

    Measured: up to 24 months after randomization

Timeline

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

  1. First posted6 Jun 2018
  2. Study start25 Sep 2018
  3. Primary completion10 Sep 2021
  4. Study completion9 Aug 2022

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545971
Sponsor's protocol ID
CIBI310A101
Status last verified
Feb 2023
First submitted
10 May 2018
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI310 and Sintilimab in people with Advanced Solid Tumors, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (time frame: up to 24 months after randomization). 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 NCT03545971.

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 28 Feb 2023.

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