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Tumor, SolidPhase 1NCT03731390

GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

A Phase 1 study testing GR1405 injection in people with Tumor, Solid and Lymphoma, run by Chinese Academy of Medical Sciences at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a Phase I clinical study for evaluating the safety, pharmacokinetics, and preliminary efficacy of repeated doses, dose escalation of GR1405 injection in patients with advanced solid tumor or lymphoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tumor, Solid, Lymphoma
What is being tested?
GR1405 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Nov 2018to Oct 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with local advanced, recurrent or metastatic solid tumors confirmed by cytology or histology Lymphoma patients with pathological confirmation, and the above pat reients failed to standard treatment failure or had no standard treatment;
  • Aged 18 to 75 years men and women;
  • At least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors v1.1(RECIST v1.1 )(solid tumor) or Lugano 2014 criteria (lymphoma);
  • Eastern Cooperative Oncology Group(ECOG)≤ 1
  • Female or male subjects of reproductive age and their mate are willing to take effective contraceptive measures for the entire treatment period and 6 months after the treatment;
  • With sufficient organ and bone marrow function;
  • At least 4 weeks after the last anti-tumor treatment before the first administration;
  • The patient or his legal representative signs a written informed consent.

Who cannot join

  • Have experienced any National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) v4.03 or greater than 3 grade irAE during previous immunotherapy treatment;
  • Has received any anti-PD-1(programmed death 1) or anti-PD-L1 antibody treatment;
  • Subjects with other malignant tumors previously or concurrently ;
  • Female patients with pregnancy or lactation;
  • Women/men who have fertility refusal to adopt contraception during the trial period;
  • Subjects with serious disease or complications, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma, uncontrolled diabetes (CTCAE= 4.03: fasting blood glucose level ≥ 2), and with active infection;
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  • Had history of acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack 6 months before the screening ,grade 2 or above congestive heart failure devised by the New York Heart Association (NYHA);
  • Subjects with symptomatic brain metastases or mental disorders;
  • Subjects with abnormal levels of serum calcium, magnesium, potassium and have clinical significance;
  • Subjects with history of immunodeficiency, including human immunodeficiency virus(HIV)-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
  • Subjects with active hepatitis B (HBsAg and/or HBcAb positive, and HBV DNA titer in peripheral blood was greater than 1 x 103 IU/ml), and/or hepatitis C;
  • Subjects who have alcohol addiction and/or drug abuse;
  • Subjects with bleeding or coagulation dysfunction in the past 3 months (Prothrombin time(PT)>1.5×upper limit of normal(ULN); activated partial thromboplastin time(APTT)>1.5×ULN; thrombin time(TT)>1.5×ULN);
  • Subjects with allergic constitution or allergic to known components of the drug;
  • Those who received other clinical trial drug therapy within 1 month before the first administration;
  • Receive a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or during the study period;
  • Other subjects judged by the investigator to be ineligible for enrollment in the study.

Trial locations and contacts

1 site in 1 country.

yuankai Shi, M.D. contact

86 010-87788293

syuankaipumc@126.com

China1 site

  • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing

Other trials in China

About this study

Official title: A Phase I Clinical Study for Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Repeated Doses, Dose Escalation of GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma

This is a Phase I clinical study for evaluating the safety, pharmacokinetics, and preliminary efficacy of repeated doses, dose escalation of GR1405 injection in patients with advanced solid tumor or lymphoma

Read the detailed description

To evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy of GR1405 injection monotherapy in an open, non-controlled, escalating trial design in patients with advanced solid tumors or lymphomas. Four dose levels (3 mg/kg, 10 mg/kg, 20 mg/kg, and 30 mg/kg) were evaluated at this stage.

Being tested
GR1405 injection
Keywords
programmed death ligand-1 (PD-L1)
Medical subject headings
Neoplasms, Lymphoma

What participants receive

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

  • GR1405 injectionDrug

    Also called PD-L1 monoclonal antibody

    Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.

Study groups in NCT03731390
Study groupRoleWhat they receive
GR1405 injection 3 mg/kgExperimentalAccording to the patient's weight, the dose of this group is 3mg/kg.
Receives: Drug: GR1405 injection
GR1405 injection 10 mg/kgExperimentalAccording to the patient's weight, the dose of this group is 10mg/kg.
Receives: Drug: GR1405 injection
GR1405 injection 20 mg/kgExperimentalAccording to the patient's weight, the dose of this group is 20mg/kg.
Receives: Drug: GR1405 injection
GR1405 injection 30 mg/kgExperimentalAccording to the patient's weight, the dose of this group is 30mg/kg.
Receives: Drug: GR1405 injection

What is being measured

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

  1. Maximum tolerated dose (MTD)

    Maximum tolerated dose of GR1405 injection

    Measured: 2 weeks

  2. Adverse Events

    Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v4.03

    Measured: Approximately 3 years

Secondary outcomes (13)

  1. maximum concentration (Cmax)

    the maximum exposure to a biologically active physica

    Measured: Approximately 2 years

  2. Duration of response (DOR)

    DOR by RECIST v. 1.1 or Lugano 2014, the time between the initial response to therapy and subsequent disease progression or relapse

    Measured: Approximately 3 years

  3. Objective Response Rate(ORR)

    Objective Response Rate(ORR) by RECIST v. 1.1 or Lugano 2014, ORR=complete response(CR) + partial response(PR)

    Measured: Approximately 3 years

  4. Progression free survival(PFS)

    Progression free survival(PFS) by RECIST v. 1.1 or Lugano 2014, a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works

    Measured: Approximately 3 years

  5. Immunogenicity

    the ability to elicit an immune response of GR1405 injection,

    Measured: Approximately 3 years

  6. Recommended dose for Phase II trial(RP2D)

    The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced dose-limiting toxicity(DLT) attributable to the study drug. The MTD will be the RP2D

    Measured: Approximately 3 years

  7. AUC0-t

    Area under the curve in the period from 0 to t

    Measured: Approximately 2 years

  8. AUC0-∞

    Area under the curve in the period from 0 to ∞

    Measured: Approximately 2 years

  9. AUCss

    Area under the curve of Steady-State Plasma Concentrations

    Measured: Approximately 2 years

  10. T max

    the time of occurrence of peak drug concentration

    Measured: Approximately 2 years

  11. t 1/2

    the time of half-life of the drug

    Measured: Approximately 2 years

  12. apparent volume of distribution (Vz)

    the volume of fluid that would be required to contain the amount of drug in the body

    Measured: Approximately 2 years

  13. clearance(CL)

    the rate of elimination of the drug in vivo

    Measured: Approximately 2 years

Timeline

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

  1. First posted6 Nov 2018
  2. Study startNov 2018 (estimated)
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2021 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731390
Sponsor's protocol ID
GR1405-002
Status last verified
Nov 2018
First submitted
2 Nov 2018
Last updated
6 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

    PubMed 28434648

  • Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.

    PubMed 27939400

  • Schachter J, Ribas A, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M, Larkin J, Lorigan P, Neyns B, Blank C, Petrella TM, Hamid O, Zhou H, Ebbinghaus S, Ibrahim N, Robert C. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017 Oct 21;390(10105):1853-1862. doi: 10.1016/S0140-6736(17)31601-X. Epub 2017 Aug 16.

    PubMed 28822576

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GR1405 injection in people with Tumor, Solid and Lymphoma, run by Chinese Academy of Medical Sciences 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 8 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: status not confirmed, as of the sponsor's last update on 6 Nov 2018. 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?

Results are not available in the source record.

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

Contact yuankai Shi, M.D. (86 010-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 2 weeks). 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 NCT03731390, which also lists 3 linked publications.

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 6 Nov 2018.

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