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Advanced/Metastatic Solid MalignanciesPhase 1NCT03568539

IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

A Phase 1 study testing IBI308 in people with Advanced/Metastatic Solid Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 7 sites in United States.

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

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Patients will be recruited for 2 cohorts: Cohort 1: Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Malignancies
What is being tested?
IBI308
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
7 sitesUnited States
Study dates
27 Jun 2018to 7 Dec 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  • Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 90 days following the last dose of study drug. Postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential.
  • Male or female subjects ≥18 years
  • At least one measurable lesion (per RECIST version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  • Subjects with life expectancy of ≥ 3 month
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  • If subject received anti-tumor therapy:
  • Generalized radiation therapy must have been completed 3 weeks prior to enrollment, or local radiotherapy or radiation therapy for bone metastases for 2 weeks prior to enrollment. Treatment with radiopharmaceuticals must have been completed 8 weeks prior to enrollment.
  • Previous chemotherapy, biotherapy (tumor vaccines, cytokines, or growth factors that control cancer), tyrosine kinase inhibitors, or approved targeting and other treatments should have completed at least 3 weeks prior to the first administered dose in this study;
  • Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI308 administration
  • Absolute neutrophil count (ANC) ≥1.5 x10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
  • Renal function tests: serum creatinine ≤1.5 ×upper limit of normal range (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2
  • Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN
  • Total bilirubin (TBil) ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
  • Coagulation tests: aPTT ≤ 1.5 x ULN and INR ≤2.0
  • Cohort Specific Inclusion Criteria:
  • Cohort 1: Advanced/metastatic cancers with high TMB expression
  • Advanced/metastatic cancers with TMB level > 10 mut/Mb ii. Histologically or cytologically confirmed unresectable Stage III/IV NSCLC or other advanced/metastatic cancers (for example, melanoma, bladder cancer, SCLC, prostate cancer, colorectal cancer, gastric cancer) iiI. Separate informed consent is required for subjects who provide fresh biopsies for serial tumor biopsies for biomarker testing. TMB testing should be performed on the most recently obtained tumor sample.
  • Subjects must be tested for TMB level before entering the study, and pre-screen informed consent is required for TMB testing. Subjects who have existing FoundationOne TMB testing results from within 6 months of study entry do not need to have repeat testing.
  • Refractory or intolerant to standard therapy or for whom no standard therapy exists. Subjects must have no available therapy likely to confer clinical benefit for their cancer. Subjects who experienced irAE grade ≥ 3, or grade 2 recurrent pneumonitis, or who had to discontinue prior anti-PD-1/PD-L1 treatment due to irAEs of any grade will not be eligible.
  • NSCLC subjects with EGFR mutation and/or ALK rearrangement and/or ROS-1 positive, should have received appropriate targeted therapy and are refractory to targeted therapy prior to enrolling this trial.
  • Cohort 2: Advanced/metastatic endometrial Cancer i. Histologically confirmed advanced/metastatic endometrial cancer. ii. Refractory or intolerant to standard therapy, and no available therapy likely to confer clinical benefit for their cancer. Subjects who experienced irAE grade ≥ 3, or who had to discontinue prior anti-PD-1/PD-L1 treatment due to irAEs of any grade will not be eligible.

Who cannot join

  • Legal incapacity or limited legal capacity.
  • Pregnancy, lactation, breastfeeding.
  • Concurrent anticancer treatment (e.g., cytoreductive therapy or cytokine therapy except for erythropoietin) or use of other investigational product within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy.
  • Note: Small molecule or antibody targeted therapy < 3 weeks from start of trial treatment will be excluded.
  • Received a biologic (G-CSF, GM-CSF) within 14 days prior to the first dose of study drug.
  • Vaccination within 4 weeks of first dose of IBI308 and while on study except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
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  • Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade 1 or baseline with the exception of alopecia;
  • Active autoimmune disease requiring systemic treatment within the past 1 year or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents during the conduct of this study. Exceptions: - Vitiligo, eczema, psoriasis (<10% of body surface area (BSA) of skin eruption or systemic involvement) or resolved childhood asthma/atopy, autoimmune hypothyroidism stable on hormone replacement.
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis.
  • Subject who have had severe infection within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
  • Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia
  • Subjects who experienced (irAE) grade≥3 immunotherapy-related adverse events. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs 14 days prior to dosing.
  • Patients who require high dose of systemic corticosteroids (>10 mg/day prednisone or equivalents) for at least 2 weeks prior to treatment are not eligible.
  • Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
  • Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Northside Hospital, Inc

    Atlanta, Georgia, 30342

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: An Open-label, Phase 1b Multicenter Study of IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.

Patients will be recruited for 2 cohorts:

Read more
  • Cohort 1: Advanced/metastatic cancers with TMB>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first.

Cohort 2: Advanced/metastatic endometrial cancer (N=40)

Being tested
IBI308
Keywords
Advanced/metastatic solid malignancies, TMB high

What participants receive

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

  • IBI308Drug

    IBI308 200mg IV infusion, every 3 weeks.

Study groups in NCT03568539
Study groupRoleWhat they receive
IBI308ExperimentalNot described
Receives: Drug: IBI308

What is being measured

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

  1. Overall Response Rate (Confirmed)

    To evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 29 months

Secondary outcomes (6)

  1. Progression-free Survival

    To measure progression-free survival rate (PFS) Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non- target lesion, or the appearance of new lesions

    Measured: 2 years

  2. Duration of Response

    To measure duration of response (DOR)

    Measured: 2 years

  3. Overall Survival

    To measure overall survival rate (OS)

    Measured: 2 years

  4. Number of Participants With Detectable Anti- Drug Antibodies.

    Anti-Drug Antibodies will be tested to evaluate immunogenicity of IBI308

    Measured: 2 years

  5. Area Under the Curve (AUC [0-504h])

    To evaluate the Area Under the Curve [AUC] of IBI308.

    Measured: 0-504h

  6. Maximum Plasma Concentration [Cmax]

    To evaluate the Maximum Plasma Concentration [Cmax] of IBI308.

    Measured: Cycle 1 Day 1: predose, 5 minutes, 1, 6, 24, 48, 168, and 336 hr post-end of infusion

Timeline

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

  1. First posted26 Jun 2018
  2. Study start27 Jun 2018
  3. Primary completion9 Nov 2020
  4. Study completion7 Dec 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03568539
Sponsor's protocol ID
CIBI308A102
Status last verified
May 2021
First submitted
1 May 2018
Last updated
1 Jun 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI308 in people with Advanced/Metastatic Solid Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 7 sites in United States.

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 24 inclusion and 17 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 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (Confirmed) (time frame: 29 months). 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 NCT03568539.

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 1 Jun 2021.

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